The Recall Desk

Archive

December 2012 recalls

411 recalls were announced in December 2012.

What the numbers show

Critical
23
Severe
79
High
198
Moderate
100
Low
11

Of the 411 recalls this month scored against our rubric, 6% are Critical, 19% are Severe.

1–100 of 411

  • SevereNHTSA·12E057000·2012-12-28

    Neotek Recalls DURALAST Brake Rotors Due to Fracture Risk

    Neotek is recalling DURALAST brake rotors sold at Autozone because a narrow casting area may fracture, reducing braking performance and increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·13083·2012-12-27

    Nap Nanny Infant Recliners Recalled Due to Design Defects and Infant Deaths

    Baby Matters is recalling Nap Nanny infant recliners due to design defects that pose a risk of injury and death. CPSC reports five infant deaths and numerous incidents of infants hanging or falling out.

    Product
    Nap Nanny® Generations One and Two, and the Chill™ model infant recliners
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13084·2012-12-27

    Meijer Recalls Falls Creek Kids Denim Jeans Due to Choking Hazard

    Meijer is recalling Falls Creek Kids infant and toddler denim jeans because a snap may detach, posing a choking hazard to young children.

    Product
    Falls Creek Kids infant and toddler denim jeans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0850-2013·2012-12-26

    Veggie Patch Falafel Chickpea Balls Recalled for Listeria Contamination

    Tribe Mediterranean Foods is recalling Veggie Patch Falafel Chickpea Balls due to Listeria monocytogenes contamination. The product was distributed nationwide and in Canada.

    Product
    Veggie Patch Falafel Chickpea Balls, Net Wt 9 oz tray, Refrigerated UPC code 6-10129-06619-3
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0831-2013·2012-12-26

    Whole Alternatives Recalls Dried Golden Raisins for Undeclared Sulphur Dioxide

    Whole Alternatives LLC is recalling 8-ounce packages of Dried Golden Raisins due to undeclared sulphur dioxide. The product was distributed to Harris Teeter stores in nine states and D.C.

    Product
    Dried Golden Raisins 8 oz UPC 7203670490
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·12V602000·2012-12-26

    Subaru Recalls Vehicles for Puddle Light Fire Risk

    Subaru is recalling certain 2006-2012 vehicles because accessory puddle lights may short-circuit and cause a fire.

    Product
    SUBARU — SUBARU FORESTER, TRIBECA, OUTBACK, LEGACY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0548-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and associated tools due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size E-F, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0514-2013·2012-12-26

    Bunnell Patient Circuits Recalled Due to Heater Wire Insulation Melting

    Bunnell, Inc. is recalling Patient Circuits used with the Life Pulse High Frequency Ventilator because heater wire insulation can melt, causing sparking and smoke.

    Product
    Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0577-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0542-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE F, LEFT TIBIA SIZE F RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0825-2013·2012-12-26

    Red Chamber Recalls Frozen Yellowfin Tuna Loin Due to Illness Complaints

    Red Chamber Company is recalling frozen yellowfin tuna loin after customer complaints of scromboid illness. The recall covers 750 cases distributed nationwide.

    Product
    Frozen Yellowfin Tuna Loin 3/5, 30lbs/case.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0550-2013·2012-12-26

    Zimmer Persona Tibial Sizing Plate Recalled for Perforation Risk

    Zimmer, Inc. is recalling Persona Tibial Sizing Plates and related tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0546-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Drill Guide

    Zimmer, Inc. is recalling 94 units of the Persona Tibial Drill Guide to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Drill Guide, Cemented, 15.7 mm Diameter, Nonsterile, Nonsterile This drill guide is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-093-2013·2012-12-26

    Physicians Total Care Recalls Procrit Injection Due to Glass Delamination

    Physicians Total Care is recalling Procrit (epoetin alfa) injection vials because of glass delamination and particulate matter. The recall affects 20 vials distributed in Pennsylvania and California.

    Product
    Procrit (epoetin alfa) injection, 20000 units/mL, 4 mL vial; Mfg By: Amgen Inc., Thousand Oaks, CA 91320; Dist. By: Physicians Total Care, Tulsa, OK 74146; NDC 54868-5673-1.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-096-2013·2012-12-26

    Hospira Recalls Nalbuphine Hydrochloride Injection Due to Sterility Concerns

    Hospira is recalling 145,400 vials of Nalbuphine Hydrochloride Injection because loose crimps and missing stoppers prevent assurance of sterility.

    Product
    NALBUPHINE HYDROCHLORIDE — NALBUPHINE HYDROCHLORIDE (NALBUPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0824-2013·2012-12-26

    Krasnyi Oktyabr Recalls Imported Dried Rudd Fish for Contamination

    Krasnyi Oktyabr Inc. is recalling imported dried rudd fish found to be uneviscerated. The product was distributed in New York City.

    Product
    "beer set dried rudd", NET WT 200 g (7 oz), PRODUCT OF RUSSIA, BEST BEFORE 10.22.2012 --- The product was packaged in a vacuum packed bag. According to the Food Lab Report, the sample consisted of two (2) whole fish measuring 8 inches and 10 inches in length.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0574-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-099-2013·2012-12-26

    Hospira Recalls Lidocaine Hydrochloride Injection Due to Particulate Matter

    Hospira is recalling Lidocaine Hydrochloride Injection vials because visible particulate matter embedded in the glass wall may dislodge into the product.

    Product
    LIDOCAINE HYDROCHLORIDE — LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0549-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Related Tools

    Zimmer, Inc. is recalling 92 units of Persona Knee System Tibial Broaches and related tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach, Cemented, Size G-H, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0544-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

    Zimmer, Inc. is recalling 195 Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE H, LEFT TIBIA SIZE H RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0552-2013·2012-12-26

    Zimmer Persona Knee System Tibial Sizing Plates Recalled for Perforation Risk

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size E Left; Size E Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0553-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 188 Persona Tibial Sizing Plates due to a risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size F Left; Size F Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0539-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling 318 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile SIZE C, LEFT; SIZE C RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0541-2013·2012-12-26

    Zimmer Persona Knee System Recalled for Tibial Perforation Risk

    Zimmer, Inc. is recalling Persona knee system tibia implants and tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE E, LEFT TIBIA SIZE E RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0849-2013·2012-12-26

    Tribe Mediterranean Foods Recalls Veggie Patch Meatless Burgers for Listeria

    Tribe Mediterranean Foods is recalling two varieties of Veggie Patch Ultimate Meatless Burgers due to contamination with Listeria monocytogenes.

    Product
    Meatless Burger: 1) Veggie Patch Ultimate Meatless Burger - Net Wt. 9 oz. tray, UPC Code 6-10129-00211-5; 2) Veggie Patch The Ultimate Meatless Burger - Le burger sans-viande ultime, Net Wt 1.02Kg/ 2.25 Lb, UPC Code: 6-10129-08477-7
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0547-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Broach and Associated Tools

    Zimmer, Inc. is recalling Persona Knee System tibial broaches and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Broach,, Cemented, Size C-D, Nonsterile, This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Col
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0543-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants to Reduce Tibial Perforation Risk

    Zimmer, Inc. is recalling 346 units of Persona knee system tibia implants and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile TIBIA SIZE G, LEFT TIBIA SIZE G RIGHT This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0557-2013·2012-12-26

    ThyssenKrupp LEVANT Stairlifts Recalled Due to Seat Breakage Risk

    ThyssenKrupp Access Corp is recalling 5,413 LEVANT stairlifts because the seat could break if the seat belt is trapped underneath the foldable part.

    Product
    ThyssenKrupp Accessibility LEVANT Stairlift. Intended to mechanically transport one mobility impaired person in a fold-down seat up and down straight stairs, indoors and outdoors.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0554-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size G Left; Size G Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0585-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS L 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0591-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2013·2012-12-26

    Biomet Recalls Offset Tibial Tray Adaptors Due to Sizing Issue

    Biomet is recalling 200 offset tibial tray adaptors because the locking insert may not engage the tool, potentially delaying surgery and increasing anesthesia time.

    Product
    Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain femoral heads.

    Product
    SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS L 9IN CALC 2.25/21 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0832-2013·2012-12-26

    Clam Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Clam Base products because the ingredient label failed to identify milk, a major allergen, as a source of butter and cream.

    Product
    #122-A, Piazza Produce Clam Base, Net Weight 16 oz (1 lb) 454G Packed For: Piazza Produce, Indianapolis, IN 46268: #122-A, Primarque Clam Base, Net Wt 16 oz (1 lb) 454 grams Manufactured for Primarque Products Co. Worcester, MA 01610 #122-A, Clam Base, Cook's Delight Clam
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0834-2013·2012-12-26

    Primarque Clam Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Primarque Clam Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #223-E Primarque Clam Base, Net Weight 50 pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0851-2013·2012-12-26

    Riviana Recalls Yellow Rice Mixes for Undeclared Soy Protein

    Riviana International is recalling specific Shurfine and Hannaford yellow rice mixes because they contain undeclared hydrolyzed soy protein.

    Product
    Yellow rice mixes with the following g brand names: (1) Shurfine brand Yellow Rice with Saffron, NET WT 5 OZ (142g), distributed by TOPCO ASSOCIATES, LLC, 7711 GROSS POINT ROAD, SKOKIE, IL 60077. UPC 011161159834 and (2) Hannaford brand Yellow Rice with real saffron & other sea
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0531-2013·2012-12-26

    Varian ARIA Radiation Oncology System Recall for DICOM Export Anomaly

    Varian Medical Systems is recalling ARIA Oncology Information System units due to a software anomaly where 360-degree arc fields may convert to static fields during DICOM import or export.

    Product
    Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiation Oncology, Import Export Application, Model Number: HIT, Affected Versions: ARIA version 11.0 below 11.0.55, Build 11.0.28 and 11.0.34, Reference/FSCA Identifier: CP-09798; Product is manufactured an
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0843-2013·2012-12-26

    Primarque Lobster Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque Lobster Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #326 RS PrimarqueLobster Base, Net Weight 50 Pounds;, PackedFor Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0840-2013·2012-12-26

    Mushroom Base Recalled for Missing Milk Allergen Labeling

    Williams West & Witt's Products Company is recalling Cook's Delight Mushroom Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #272N Cook's Delight Mushroom Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0837-2013·2012-12-26

    Primarque Fish Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque Fish Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #425N Primarque Fish Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0551-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size D Left; Size D Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS R 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock as intended with certain femoral heads.

    Product
    SOL SYS L 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2013·2012-12-26

    BioHorizons AutoTac Delivery Handle Recalled for Insufficient Cleaning Instructions

    BioHorizons is recalling 174 AutoTac Delivery Handles because cleaning instructions may not remove residual contaminants after surgical use.

    Product
    AutoTac Delivery Handle, REF 400-200, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain femoral heads, preventing the stem and head from locking as intended.

    Product
    SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2013·2012-12-26

    Zimmer Recalls Persona Tibial Drills to Reduce Perforation Risk

    Zimmer, Inc. is recalling 135 Persona Tibial Drills and associated tools to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System,Tibial Drill, Cemented, 15.7 mm Diameter, Nonsterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0838-2013·2012-12-26

    Williams West & Witt's Recalls Clam Base for Unlabeled Milk Allergen

    Williams West & Witt's is recalling Primarque Clam Base because the label failed to identify milk as an ingredient. Consumers with milk allergies are at risk of serious allergic reactions.

    Product
    #822- M PrimarqueClam Base, Net Weight 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0589-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0841-2013·2012-12-26

    Cook's Delight Shrimp Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Shrimp Base because the label failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #828 Cook's Delight Shrimp Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0835-2013·2012-12-26

    Lobster Base Recalled for Missing Milk Allergen Labeling

    Williams West & Witt's is recalling specific lobster base products because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #124-M Primarque Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #124-M Cook's Delight Lobster Base, Net Weight (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360 #124-M
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0601-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0833-2013·2012-12-26

    Clam Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque and Cook's Delight Clam Base because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #222-C, Primarque Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed for Primarque Products, Worcester, MA 01610 #222-C, Cook's Delight Clam Base, Net Weight 5 pounds (2.27kg) & 16 oz ( 1 LB) 454G Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0588-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0600-2013·2012-12-26

    Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure fun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0567-2013·2012-12-26

    Medtronic Recalls 140 DBS Extension Kits with Damaged Connector Boots

    Medtronic is recalling 140 Deep Brain Stimulation Extension Kits because the connector boots may be cracked or improperly molded.

    Product
    Medtronic, DBS Extension Kit for Deep Brain Stimulation, Catalog # 7482, 37085, 37086. Rx Only, Manufactured in: Medtronic, Inc. Villalba, Puerto Rico. Medtronic¿ DBSTM Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subtha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2013·2012-12-26

    Invacare Recalls Height Adjustable Walking Canes Due to Collapse Risk

    Invacare is recalling height adjustable walking canes because the height-lock button may compress unexpectedly, causing the cane to collapse and potentially injure the user.

    Product
    Invacare Height Adjustable (walking) Canes, Model Numbers: 8916, 8917, and 40918-6. The device is packaged six (6) canes per shipping carton. The cane is used as an aid in walking or ambulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow accuracy issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0580-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled Due to Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS L 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0842-2013·2012-12-26

    Cook's Delight Lobster Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Lobster Base because the label failed to identify milk as an ingredient. Consumers with a milk allergy are at risk of serious allergic reactions.

    Product
    #226 Cook's Delight Lobster Base, Net Weight 30 Pounds; 5 Pounds, Packed by Integrative Flavors, Michigan City, Indian
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0540-2013·2012-12-26

    Zimmer Recalls Persona Knee Implants Due to Tibial Perforation Risk

    Zimmer, Inc. is recalling 518 units of Persona Knee System tibial implants and tools to reduce the risk of tibial perforation and fracture.

    Product
    Persona The Personalized Knee System, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile This device is indicated for patients with severe knee pain and disability due to: o Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disord
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2013·2012-12-26

    GE Healthcare Recalls Advantage Workstation Software Due to Vessel Label Mismatch

    GE Healthcare is recalling specific Advantage Workstation software versions due to a potential vessel label mismatch and a measurement tool refresh issue that may impact patient safety.

    Product
    Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 and 3.1 (version7.0 to version7.5 and version 8.1) and only when or more of these applications is installed: " VesselIQ Xpress or AVA Xpress " CardIQ Xpress Pro or Plus " CardEP " CardIQ Fusion PET or
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0599-2013·2012-12-26

    Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Accuracy Issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2013·2012-12-26

    Zimmer Recalls Coonrad/Morrey Total Elbow Replacement Sets Due to Pin Error

    Zimmer, Inc. is recalling specific lots of Coonrad/Morrey Total Elbow Replacement Sets because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0605-2013·2012-12-26

    Bayer Recalls Medrad Continuum MR Infusion System Tubing Sets

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure funct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS L 9IN CALC 2.25/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2013·2012-12-26

    GE Healthcare Recalls Dash Patient Monitors Due to NBP Cycling Issue

    GE Healthcare is recalling 119,260 Dash 3000/4000/5000 patient monitors due to a potential issue where Custom Automatic NBP Measurement cycling may stop unexpectedly.

    Product
    GE Healthcare, Dash 3000/4000/5000. The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0836-2013·2012-12-26

    Seafood Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's is recalling Primarque and Cook's Delight Seafood Base because the label failed to identify milk as an ingredient.

    Product
    #126 Primarque Seafood Base, Net Weight 16 oz, 1LB, 454 G & 50 Pounds (22.68 kg) Packed for Primarque Products, Worcester, MA 01610 #126 Cook's Delight Seafood Base, Net Weight 16 oz (1LB) 454 G & 50 Pounds (22.68 kg) Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0573-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may not lock properly with certain femoral heads.

    Product
    SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0587-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may impinge with certain heads, preventing them from locking as intended.

    Product
    SOL SYS R 9IN CALC 2.25/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2013·2012-12-26

    DePuy Solution Calcar Stems Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0844-2013·2012-12-26

    Crab Base Products Recalled for Undeclared Milk Allergen

    Williams West & Witt's recalls Primarque and Cook's Delight crab base products because the labels failed to identify milk as an ingredient, posing a risk to consumers with milk allergies.

    Product
    #321N Primarque Crab Base, Net Weight 50 Pounds, Packed For Primarque Products, Worcester, MA 01610 #321 N Cook's Delight,Crab Base, Net Weight 50 Pounds, Packed By Integrative Flavors, Michigan City, Indiana 46360
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0603-2013·2012-12-26

    Medrad Continuum MR Infusion System tubing sets recalled for flow rate issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0583-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling 1,732 Solution Calcar Stems because engineering analysis found they may not lock properly with certain femoral heads, posing a risk of impingement.

    Product
    SOL SYS L 9IN CALC 2.25/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0586-2013·2012-12-26

    DePuy Orthopaedics Recalls Solution Calcar Stems Due to Impingement Risk

    DePuy Orthopaedics is recalling Solution Calcar Stems used in hip replacements because an engineering analysis found they may not lock properly with certain heads.

    Product
    SOL SYS F 9 CALC L 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0570-2013·2012-12-26

    BD Phoenix PMIC-108 Panels Recalled for False Susceptibility Test Results

    Becton Dickinson is recalling 12,250 BD Phoenix PMIC-108 panels because they may produce false intermediate or resistant antibiotic susceptibility results.

    Product
    BD Phoenix PMIC-108 Panels, Catalog number 448418, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, USA. The BD Phoenix" Automated Microbiology system is intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2013·2012-12-26

    Arobella Medical 6mm Qurette Recalled for Fracture Risk During Use

    Arobella Medical is recalling 6mm Qurettes used in the AR1000 Wound Therapy System because they can fracture during use and release fragments.

    Product
    Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, done-shaped applicator tip (qurette), and a saline supply reservoir. Product
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2013·2012-12-26

    GE Healthcare Recalls Carescape Patient Data Module Software

    GE Healthcare is recalling Carescape Patient Data Module units with v2.0 software due to two issues that may impact patient care.

    Product
    GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0562-2013·2012-12-26

    BioHorizons Recalls Titanium Tack Starter Kits Due to Cleaning Instructions

    BioHorizons is recalling 1,246 units of Titanium Tack Starter Kits because the provided cleaning instructions may not remove residual contaminants after surgical use.

    Product
    Titanium Tack Starter Kit, REF 400-270, Rx Only, non-sterile, BIOHORIZONS, BIRMINGHAM, AL 35244. Dental.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0566-2013·2012-12-26

    Stryker Power-LOAD Ambulance Cot Fastener System Recall for Load Switch Defect

    Stryker is recalling 24 Model 6390 Power-LOAD systems because a load switch slide may not meet specifications, negatively impacting the lifting ability of the arms.

    Product
    The Stryker Model 6390, Power-LOAD, is a power-loading cot fastener system designed to lift, lower, or steer ambulance cots into and out of the ambulance.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0592-2013·2012-12-26

    DePuy Solution Calcar Stem Recalled for Potential Impingement

    DePuy Orthopaedics is recalling Solution Calcar Stems because an engineering analysis found they may impinge with certain heads, preventing proper locking.

    Product
    SOL SYS R 9IN CALC 2.25/22.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0839-2013·2012-12-26

    Shrimp Base Recalled for Undeclared Milk Allergen

    Williams West & Witt's Products Company is recalling Cook's Delight Shrimp Base because the label failed to identify milk as an ingredient.

    Product
    #428N Cook's Delight Shrimp Base, Net Weight 50 Pounds (22.68 kg) Packed by Integrative Flavors, Michigan City, Indiana
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0555-2013·2012-12-26

    Zimmer Recalls Persona Knee System Tibial Sizing Plates

    Zimmer, Inc. is recalling 189 Persona Knee System Tibial Sizing Plates to reduce the risk of tibial perforation and bone fracture.

    Product
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size H Left; Size H Right This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0595-2013·2012-12-26

    Bayer Recalls Medrad Continuum MR Infusion Pump Tubing Sets

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while eit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0559-2013·2012-12-26

    Integra Recalls Mayfield Skull Clamps Due to Performance Issues

    Integra LifeSciences is recalling eight Mayfield Composite Series Skull Clamps (Model A3059) due to product performance issues that could impact functionality.

    Product
    MAYFIELD Composite Series Skull Clamps, Model A3059, 510(k) #K120633. The MAYFIELD Skull Clamps (A3059) are indicated for use in open and percutaneous craniotomies, as well as spinal surgery when rigid skeletal fixation is necessary.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0564-2013·2012-12-26

    BD Recalls Oral Dispensing Syringes Due to Mixed Tip Complaints

    Becton Dickinson is recalling 2,786,000 units of 1 mL Oral Dispensing Syringes because a complaint reported mixed oral and non-oral syringe tips within the same lot.

    Product
    Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com BD, Laagstraat 57, B-9140 Temse, Belgium On 100 unit plastic bag: BD oral syringes are intended to dispense oral medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0569-2013·2012-12-26

    DePuy Recalls Pinnacle Cancellous Screws Due to Labeling Error

    DePuy Orthopaedics is recalling 118 Pinnacle Cancellous Screws because the labels incorrectly identify them as Cannulated Screws.

    Product
    Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard carton, labeled and shrink-wrapped. PINNACLE¿ CANCELLOUS Bone Screws are ancil
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0847-2013·2012-12-26

    Arnold's Candies Root Beer Puffs Recalled for Missing Color Labeling

    Arnold's Candies is recalling Root Beer Puffs because the label failed to list Yellow #5 and Blue #1. The product was distributed in New York, Ohio, and Pennsylvania.

    Product
    Arnold's Candies Handmade Since 1953 www.arnoldscandies.com Root Beer Puffs Puffs***INGREDIENTS: Sugar, Cream of Tarter, Artificial Flavoring and Coloring WARNING: Manufactured in a facility that also handles peanuts NET WT 6 oz (170g) 0 73629 00307 3 931 High Grove Blvd Akron,
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0828-2013·2012-12-26

    Garden Fresh Recalls El Matador Salted Tortilla Chips for Quality Standards

    Garden Fresh Salsa, Inc. is recalling El Matador Salted Tortilla Chips because the ingredients used did not meet quality standards.

    Product
    El Matador Mexican Style Salted Tortilla Chips 16oz (454 g) bags &32 oz (908 g) bags
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0526-2013·2012-12-26

    EEG Info Recalls EEG NeuroAmp Devices Due to Mislabeling

    EEG Info is recalling EEG NeuroAmp devices because of a potential risk associated with mislabeling.

    Product
    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0538-2013·2012-12-26

    Zimmer Recalls Coonrad/Morrey Elbow Replacement Kits Due to Pin Error

    Zimmer is recalling specific lots of Coonrad/Morrey elbow replacement kits because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    Coonrad/Morrey New Ulnar Revision Kit for Use with Non-Interchangeable Regular Humerals STERILE Rx, Tivanium QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the soli
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0596-2013·2012-12-26

    Medrad Continuum MR Infusion System Tubing Sets Recalled for Flow Rate Issues

    Bayer HealthCare is recalling Medrad Continuum MR Infusion System tubing sets because a variation may cause flow rate accuracy issues when used with Continuum pumps.

    Product
    Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR p
    Category
    Medical Device
    Distribution
    Distributed nationwide

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