The Recall Desk

Archive

November 2012 recalls

569 recalls were announced in November 2012.

What the numbers show

Critical
111
Severe
99
High
164
Moderate
162
Low
33

Of the 569 recalls this month scored against our rubric, 20% are Critical, 17% are Severe.

Which agencies issued them

301–400 of 569

  • CriticalFDA (Food)·F-0637-2013·2012-11-14

    Jamba Juice Chunky Strawberry Topper Recalled Due to Salmonella Risk

    Jamba Juice is recalling Chunky Strawberry Topper because it was made with peanut butter that may be contaminated with Salmonella.

    Product
    Jamba Juice brand Chunky Strawberry Topper; All sizes (small, medium, large); A Blend Of: Strawberries, Bananas, Nonfat Plain Yogurt (Contains Milk), Soymilk (Contains Soy), Organic Pumpkin Flax Seed Granola (Contains Soy & Wheat), Peanut Butter (Contains Peanuts); Product is pr
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0605-2013·2012-11-14

    Kent's and Keitt's Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to a salmonella association.

    Product
    Mixes, Salsa Mango Papaya, Ready-To-Eat Product, 2, 5-lb trays per case
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0628-2013·2012-11-14

    Think Thin Nutrition Bars Recalled for Potential Salmonella Contamination

    Think Thin, LLC is recalling Crunch thinkThin Blueberry & Mixed Nuts nutrition bars because they may contain peanuts contaminated with Salmonella.

    Product
    Nutrition bar. Crunch¿ thinkThin Brand, Blueberry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0614-2013·2012-11-14

    Earthbound Farms Organic Baby Spinach Salad Recalled for Salmonella Risk

    Earthbound Farms is recalling Organic Baby Spinach Grab & Go Salads because the peanuts included in the package may be contaminated with Salmonella.

    Product
    Earthbound Farms Organic Baby Spinach Grab & Go Salad; with sesame, soy vinaigrette and peanuts. USDA Organic 3.5 oz. Clamshell package. UPC 0 32601 08875 0 Natural Selection Foods San Juan Bautista, CA.
    Category
    Food
    Distribution
    13 states
  • CriticalFDA (Food)·F-0638-2013·2012-11-14

    JagRma Recalls NuttZo Nut Butter Due to Salmonella Contamination Risk

    JagRma LLC is recalling NuttZo Original Nut and Seed Butter because it may be contaminated with Salmonella from a peanut butter ingredient supplied by Sunland, Inc.

    Product
    Organic NuttZo Omega-3 SEVEN Nut & Seed Butter, Net Wt. 16 oz (1lb) 454 g, UPC 894697002030.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0619-2013·2012-11-14

    Velvet Ice Cream Recalls Peanut Butter Cup Ice Cream Due to Salmonella Risk

    Velvet Ice Cream Company is recalling two peanut butter cup ice cream products because they were made with peanut butter recalled for potential Salmonella contamination.

    Product
    Peanut Butter Cup Ice Cream: 1) Velvet Supreme Peanut Butter Cup 1/2 gallon MFD BY VELVET ICE CREAM CO., INC UTICA, OHIO 43080 1-800-589-5000; UPC #70682-10119; 2) Velvet Peanut Butter Cup, 3 gal, UPC #70682-10539
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-041-2013·2012-11-14

    Northstar Zolpidem Tartrate Tablets Recalled for Foreign Valacyclovir Contamination

    Aurobindo Pharma is recalling Northstar Zolpidem Tartrate Tablets 10 mg because 30 valacyclovir tablets were found in a bottle.

    Product
    Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aurobindo Pharma Limited, Unit VII, Mahaboob Dagar, 509302, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V536000·2012-11-14

    Toyota Recalls Prius and FCHV-Adv for Water Pump Defect

    Toyota is recalling 2004-2009 Prius and 2009-2011 FCHV-Adv vehicles because a scratch in the electric water pump may cause corrosion, leading to a stall-like condition and increased crash risk.

    Product
    TOYOTA — TOYOTA PRIUS, FCHV-ADV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0652-2013·2012-11-14

    Belfonte Ice Cream Recalled for Potential Salmonella Contamination

    Belfonte Ice Cream & Dairy Foods Co is recalling specific Mama's Choice Premium Ice Cream products because the peanut butter base may be contaminated with Salmonella.

    Product
    Belfonte Mama's Choice Premium Ice Cream, Reverse Peanut Butter Pie, Peanut Butter Coated Fudge Filled Cups, Peanut Butter Flakes and Swirled Chocolate Cookie Pie Crust Ribbon in Peanut Butter Ice Cream, 56 oz. (1.66L) Belonite Ice Cream Company, Kansas City, MO
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0266-2013·2012-11-14

    Stryker Recalls Hoffman LRF Telescopic Struts Due to Breakage

    Stryker Howmedica Osteonics Corp. is recalling 165 Hoffman LRF Telescopic Struts because three complaints reported the devices breaking during load-bearing use in patients weighing over 250 lbs.

    Product
    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0271-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Faults

    Sorin Group USA is recalling S5 Perfusion Systems due to motor controller faults that may cause unintended pump stoppage during surgery.

    Product
    S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V537000·2012-11-14

    Toyota Recalls 2004-2009 Prius Vehicles for Steering Shaft Defect

    Toyota is recalling 2004-2009 Prius vehicles because steering shaft splines may be insufficiently hard, risking loss of steering ability and vehicle crashes.

    Product
    TOYOTA — TOYOTA PRIUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0604-2013·2012-11-14

    Kent's and Keitt's Brand Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to a salmonella association.

    Product
    Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0633-2013·2012-11-14

    Honolulu Baking Company Recalls Starbucks Protein Bistro Boxes

    Honolulu Baking Company is recalling Starbucks Protein Bistro Boxes containing peanut butter implicated in the Sunland Inc recall.

    Product
    Starbucks brand Protein Bistro Box. cage free egg, white cheddar cheese, multigrain muesli bread, apple slices, red grapes and peanut butter packet. Net weight: 6.8 oz. Starbucks Bistro box UPC 762111881502; Justin's honey Peanut Butter blend UPC 894455000391. Honolulu Bak
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0606-2013·2012-11-14

    Kent's and Keitt's Brand Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to salmonella associated with the producer.

    Product
    Fruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0607-2013·2012-11-14

    Kent's and Keitt's Brand Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to a salmonella association.

    Product
    Fruit Mango Peeled & Diced 1/2, Ready To Eat Product, 2, 5-LB Trays per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0272-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.

    Product
    S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0273-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.

    Product
    S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0632-2013·2012-11-14

    Starbucks Protein Bistro Box Recalled Due to Peanut Butter Allergen Issue

    Flying Food Group is recalling Starbucks Protein Bistro Boxes because they contain honey peanut butter squeeze packs involved in an expanded Justin's Nut Butter recall.

    Product
    Starbucks Protein Bistro Box, Net Wt 6.8 OZ (193g), Contains Cage-free egg, white Cheddar Cheese, multigrain muesli bread with honey peanut butter spread and fruit.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Food)·F-0612-2013·2012-11-14

    The Nut Shop Recalls Roasted Peanuts Due to Sunland Peanut Recall

    The Nut Shop is recalling Roasted Peanuts because they were manufactured using peanuts recalled by Sunland. The product was distributed in Alabama and Mississippi.

    Product
    The Nut Shop (brand) Roasted Peanuts, 3.0 oz MIN Wt.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0274-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Faults

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could cause unintended pump stoppage during surgery.

    Product
    S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0270-2013·2012-11-14

    Primus Medical Recalls Prime Bed TL500 Hospital Beds Due to Frame Collapse Risk

    Primus Medical LLC is recalling 342 Prime Bed TL500 hospital beds because retaining washers and clevis pins may fail, causing the bed frame to collapse.

    Product
    AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0275-2013·2012-11-14

    Sorin C5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause pump stoppage during surgery.

    Product
    Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-040-2013·2012-11-14

    Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits

    Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.

    Product
    Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-0627-2013·2012-11-14

    Think Thin Nutrition Bars Recalled for Potential Salmonella Contamination

    Think Thin, LLC is recalling Cherry & Mixed Nuts nutrition bars that may contain peanuts contaminated with Salmonella.

    Product
    Nutrition bar. Crunch¿ thinkThin Brand, Cherry & Mixed Nuts, 40 grams. Packaged in plastic, labeled as:"Distributed by thinkproducts***Ventura, CA 93003***". 10 bars/carton, 12 cartons/case. 120 bars per case
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0621-2013·2012-11-14

    Hannaford Red Velvet Cake Truffles Recalled for Undeclared Allergens

    Hannaford Bros. is recalling Red Velvet Cake Truffles because the labels fail to declare egg, milk, peanuts, wheat, soy, and tree nuts.

    Product
    Hannaford Red Velvet Cake Truffle, 6 count UPC #20335800000
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-0257-2013·2012-11-14

    Kimberly-Clark Recalls Sterile Surgical Gowns Due to Potential Seal Failure

    Kimberly-Clark is recalling sterile surgical gowns because package seams may not remain sealed, potentially compromising sterility.

    Product
    ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0595-2013·2012-11-14

    Turkey Hill Ice Cream Recalled for Undeclared Coconut Allergen

    Turkey Hill Mint Chocolate Chip Ice Cream is being recalled because it contains undeclared coconut, a potential allergen.

    Product
    Turkey Hill Mint Chocolate Chip All Natural Ice Cream, 48 oz, UPC 0-20735-11203-8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0655-2013·2012-11-14

    Crab-Filled Fritters Recalled for Undeclared Allergens

    Fabrica Confecciones Soto, Inc. is recalling 160 units of 'Alcapurria Jueyes' (crab-filled fritters) sold in Puerto Rico due to undeclared allergens.

    Product
    "Alcapurria Jueyes" (Crab-filled fritters) - Food Service
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0602-3013·2012-11-14

    Kellogg's Mini-Wheats Variety Packs Recalled for Metal Mesh Fragments

    Kellogg's is voluntarily recalling specific Mini-Wheats variety packs due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Variety and Assortment Packs containing Frosted/ Unfrosted Mini Wheats, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 10 ct; 30 ct, 72 ct , 96 ct.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0603-2013·2012-11-14

    Kellogg's Mini-Wheats Cereal Recalled for Possible Metal Mesh Fragments

    Kellogg's is voluntarily recalling specific batches of Mini-Wheats cereal due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Canadian Product: Kellogg's Mini Wheats, Brown Sugar Flavour Cereal, 6 ct., 10 ct, 12 ct, 16ct; 400G, 510G, 850 G, 1300 G
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0609-2013·2012-11-14

    Kent's and Keitt's Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to a salmonella association.

    Product
    Mixes, Salsa Mango Bucket, Ready To Eat Product, 1 Gal; & Salsa Mango packaged in 5-lb Trays with 2 trays per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0600-2013·2012-11-14

    Kellogg's Frosted Mini-Wheats Cereal Recalled for Metal Mesh Fragments

    Kellogg's is voluntarily recalling Frosted Mini-Wheats cereal due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Frosted Mini Wheats , Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 96 ct case single serve,each Nt. Wt. 1 oz (28g); 18 oz carton; 24 oz carton; 30 oz., 70 ct case single serve, 70 oz carton Canadian product: Kellogg's Mini-Wheats Original Frosted Cereal 440
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2013·2012-11-14

    Sendx Medical Recalls ABL80 FLEX CO-OX Analyzers Due to Software Error

    Sendx Medical Inc. is recalling 767 ABL80 FLEX CO-OX analyzers because a software issue may cause incorrect reporting of hemoglobin fractional parameters.

    Product
    ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0204-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0267-2013·2012-11-14

    Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk

    Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.

    Product
    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0196-2013·2012-11-14

    Spacelabs Healthcare Recalls Xprezzon Bedside Monitor Touchscreen Displays

    Spacelabs Healthcare is recalling 169 Xprezzon bedside monitor touchscreen displays because alarm lights may fail to illuminate upon installation.

    Product
    The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0601-2013·2012-11-14

    Kellogg's Mini-Wheats Cereal Recalled for Possible Metal Fragments

    Kellogg's is voluntarily recalling specific Mini-Wheats cereal products due to the possible presence of flexible metal mesh fragments from a faulty manufacturing part.

    Product
    Kellogg's Mini Wheats, Unfrosted, Bite Size, Lightly Sweetened Whole Grain Wheat Cereal, 18 oz carton; 70 ct case single serve; Canadian: Kellogg's Mini-Wheats Original cereal 12 ct, 850 G
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0616-2013·2012-11-14

    Trifecta Foods Recalls Peanuts Due to Salmonella Contamination Risk

    Trifecta Foods is voluntarily recalling in-shell roasted peanuts supplied by Sunland, Inc. because they may be contaminated with Salmonella.

    Product
    Peanuts in Shell, R&S, 8oz, Item#304, 12pk/case, UPC 070334003046. Peanuts in Shell, R&S, 8oz, Item#304P, 12pk/case, UPC 170334003046. Peanuts in Shell, R&S, 8oz, Item#307, 36pk/case, UPC 070334003046. Peanuts in Shell, R&S, 16oz, Item#317, 24pk/case, UPC 070334003176. Peanut
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0208-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 73 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2013·2012-11-14

    Sunquest Phlebotomy Interface Software Recall for Inappropriate Order Combination

    Sunquest Information Systems is recalling 9 units of its Outbound Phlebotomy Point of Care Interface software due to confirmed reports of inappropriate patient order combination.

    Product
    Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0268-2013·2012-11-14

    Kerr Recalls AlgiNot Dental Impression Material Due to Curing Defect

    Kerr Corporation is recalling AlgiNot dental impression material because it may cure harder than expected, potentially causing tooth fractures in patients with loose teeth.

    Product
    The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0611-2013·2012-11-14

    Kent's and Keitt's Brand Mangoes Recalled Due to Salmonella Risk

    Coast Citrus Distributors is voluntarily recalling Kent's and Keitt's brand mangoes packed at Agricola Daniella due to a salmonella risk associated with the producer.

    Product
    Mixes Salsa/Mango Pineapple, Ready To Eat Product, 2, 5-lb Trays per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0634-2013·2012-11-14

    Fiesta Mix Recalled for Undeclared Allergens and Food Dye

    The Nut Factory Inc. is recalling 25-pound bags of Fiesta Mix due to undeclared soy, milk, wheat, and FD&C Yellow #6.

    Product
    Fiesta Mix 25 pound bags, with UPC 032491208597. The product is labeled in part: "***Fiesta Mix A Blend of the Sweet Crunchy and Salty Ingredient: Peanuts, honey, chili bits, corn, goldfish, nacho flavoring, vegetable oil, salt. *** 25 pounds (11.34 kg) net weight *** The Nut
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0258-2013·2012-11-14

    Kimberly-Clark Recalls MicroCool Sterile Surgical Gowns Due to Seal Defects

    Kimberly-Clark is recalling specific lots of MicroCool sterile surgical gowns because package seams may not be properly sealed, potentially compromising sterility.

    Product
    MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0654-2013·2012-11-14

    Crab Tacos Recalled for Undeclared Allergens and Food Dye

    Fabrica Confecciones Soto, Inc. is recalling 180 units of "Tacos de Jueyes" (Crab Tacos) sold in Puerto Rico due to undeclared allergens and yellow #5.

    Product
    "Tacos de Jueyes" (Crab Tacos) - Food Service
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0203-2013·2012-11-14

    FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

    Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Drugs)·D-043-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree 24 Hour Severe Acne Clearing System

    Valeant Pharmaceuticals is recalling AcneFree 24 Hour Severe Acne Clearing System cartons because the benzoyl peroxide ingredient is subpotent and the product is mislabeled.

    Product
    AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Corrective Toner AFSV-0201-01, 1-count 2 fl oz (59 mL) bottle Maximum Strength Repair Lot
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0648-2013·2012-11-14

    Penn State Creamery Recalls Ice Cream and Frozen Yogurt Due to Plastic Objects

    Penn State Creamery is voluntarily recalling ice cream and frozen yogurt produced between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry Cheesecake flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-049-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Acne Pore Cleanser

    Valeant Pharmaceuticals is recalling AcneFree Acne Pore Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.

    Product
    AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0265-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 3 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0210-2013·2012-11-14

    Zimmer Recalls Alloclassic SL Shafts for Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Alloclassic SL Shafts manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Alloclassic SL Shaft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0255-2013·2012-11-14

    Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias

    Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.

    Product
    Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0233-2013·2012-11-14

    Zimmer Anatomical Shoulder Fracture Humeral Head Label Correction

    Zimmer, Inc. is correcting patient labels for 26 Anatomical Shoulder Fracture Humeral Head units due to discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Fracture Humeral Head
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-045-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Benzoyl Peroxide Tubes Nationwide

    Valeant Pharmaceuticals is recalling 619,029 tubes of AcneFree Original Strength Terminator because the product is subpotent and mislabeled.

    Product
    AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0646-2013·2012-11-14

    Penn State Creamery Recalls Ice Cream and Frozen Yogurt Due to Plastic Objects

    Penn State Creamery is voluntarily recalling ice cream and frozen yogurt made between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chocolate Nut flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0647-2013·2012-11-14

    Penn State Creamery Recalls Strawberry Ice Cream Due to Plastic Foreign Objects

    Penn State Creamery is voluntarily recalling strawberry ice cream and frozen yogurt due to reports of small plastic foreign objects in the product.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0640-2013·2012-11-14

    Penn State Creamery Recalls Ice Cream and Frozen Yogurt Due to Plastic Fragments

    Penn State Creamery is voluntarily recalling ice cream and frozen yogurt made between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Scholar's Chip flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0211-2013·2012-11-14

    Zimmer Recalls Ceramic Femoral Heads Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for Biolox delta Ceramic Femoral Heads manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Biolox¿ delta Ceramic Femoral Head Rx only, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0641-2013·2012-11-14

    Penn State Creamery Recalls Ice Cream and Frozen Yogurt Due to Plastic Fragments

    Penn State Creamery is voluntarily recalling ice cream and frozen yogurt produced between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects in the product.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Strawberry-No Sugar Added flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-044-2013·2012-11-14

    Valeant Recalls Subpotent AcneFree Oil-Free Acne Cleanser

    Valeant Pharmaceuticals is recalling AcneFree Oil-Free Acne Cleanser because the benzoyl peroxide ingredient is subpotent and the label contains errors regarding inactive ingredients.

    Product
    AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0226-2013·2012-11-14

    Zimmer Anatomical Shoulder Glenoid Components Recalled for Labeling Discrepancies

    Zimmer Inc. is correcting patient labels on specific shoulder glenoid components due to discrepancies between product and patient labels regarding reference and lot numbers.

    Product
    zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0234-2013·2012-11-14

    Zimmer Recalls 18 CLS Stem Implants Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for 18 CLS Stem implants manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    CLS Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0252-2013·2012-11-14

    Diagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts

    Diagnostica Stago is recalling 237 STA Satellite Automated Multi-Parameter Analyzers because they may print incorrect INR values when using an external printer.

    Product
    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant ther
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0644-2013·2012-11-14

    Penn State Creamery Recalls Cookies-N-Cream Ice Cream Due to Plastic Fragments

    Penn State Creamery is voluntarily recalling Cookies-N-Cream ice cream due to reports of small plastic foreign objects in the product.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Cookies-N-Cream flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0645-2013·2012-11-14

    Penn State Creamery Recalls Ice Cream and Frozen Yogurt Due to Plastic Objects

    Penn State Creamery is voluntarily recalling ice cream and frozen yogurt made between May 16, 2012, and August 11, 2012, due to reports of small plastic foreign objects.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Chocolate Chip Cookie Dough flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0260-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu Medical Systems is recalling 665 R-30H Diagnostic X-Ray Beam-Limiting Devices because they may not comply with 2006 product performance standards regarding beam quality.

    Product
    R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2013·2012-11-14

    Zimmer Recalls Dynesys Universal Spacers Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys Universal Spacers manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Universal spacer 6-45
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0239-2013·2012-11-14

    Zimmer Recalls Dynesys Revision Set Screws Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys Revision set screws manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Revision + set screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0218-2013·2012-11-14

    Zimmer Recalls Distal Centralizers Due to Labeling Discrepancy Complaints

    Zimmer Inc. is correcting patient labels for MS-30 Distal Centralizers manufactured before March 2010 after receiving four complaints regarding reference and lot number discrepancies.

    Product
    MS-30¿ Distal centralizer, cemented, sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0262-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu is recalling 288 mobile X-ray systems and related components because they may not meet federal standards for beam quality.

    Product
    0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0212-2013·2012-11-14

    Zimmer Recalls BioloX Option Ceramic Femoral Heads Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for BioloX Option Ceramic Femoral Head Systems manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Biolox¿ Option Ceramic Femoral Head System Rx, sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0261-2013·2012-11-14

    Shimadzu Recalls Diagnostic X-Ray Beam-Limiting Devices for Performance Non-Compliance

    Shimadzu is recalling 308 R-20J Diagnostic X-Ray Beam-Limiting Devices because they may not meet 2006 FDA performance standards for beam quality.

    Product
    R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2013·2012-11-14

    Surgical Specialties Recalls Sharpoint IQ Slit Knives Due to Bent Tips

    Surgical Specialties is recalling Sharpoint IQ Geometry Slit Knives because the tips may be bent. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0259-2013·2012-11-14

    AMS AdVance Male Sling System Recalled for Suture Degradation

    American Medical Systems is voluntarily recalling the AdVance Male Sling System because the resorbable suture may degrade before the 15-month shelf life expires.

    Product
    AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2013·2012-11-14

    Sechrist Hyperbaric Chamber Software Bug Recall

    Sechrist Industries is recalling 65 monoplace hyperbaric chambers to fix a software bug that could affect performance.

    Product
    Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0201-2013·2012-11-14

    FDA Recalls Sharpoint IQ Slit Knives Due to Potential Bent Tips

    Surgical Specialties Puerto Rico Inc. is recalling Sharpoint IQ Geometry Slit Knives because they may have bent tips. The recall affects 117,948 units distributed worldwide.

    Product
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0264-2013·2012-11-14

    Shimadzu Recalls Mobile X-ray Systems for Beam Quality Non-Compliance

    Shimadzu Medical Systems is recalling 5 mobile X-ray systems because they may not meet federal beam quality standards.

    Product
    0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0639-2013·2012-11-14

    Penn State Creamery Recalls Black Raspberry Ice Cream Due to Plastic Fragments

    Penn State Creamery is voluntarily recalling Black Raspberry ice cream and frozen yogurt due to reports of small plastic foreign objects in the product.

    Product
    Penn State Creamery/Berkey Creamery Ice Cream -- Black Raspberry flavor; 3 gallon (paper), 1/2 gallon (paper) and pints (plastic)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0235-2013·2012-11-14

    Zimmer Recalls Mueller Low Profile Cups Due to Label Discrepancies

    Zimmer Inc. is correcting patient labels for Mueller Low Profile Cups manufactured before March 2010 due to reference and lot number discrepancies.

    Product
    Original M.E. Mueller" Low Profile Cup Sterile, Rx
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0240-2013·2012-11-14

    Zimmer Recalls Dynesys HA Pedicle Screws Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Dynesys HA Pedicle screws manufactured before March 2010 due to reported discrepancies between product and patient labels.

    Product
    Dynesys¿ HA Pedicle + set screw
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0206-2013·2012-11-14

    Philips Recalls Pinnacle3 Virtual Client Connection Software Due to Improper Release

    Philips Medical Systems is recalling 11 units of Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and distribution.

    Product
    Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or mali
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0236-2013·2012-11-14

    Zimmer Recalls Dynesys Set Screws Due to Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Dynesys Set Screws manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ Set screw M6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0245-2013·2012-11-14

    Zimmer Recalls Tibial Plates Due to Patient Label Discrepancies

    Zimmer Inc. is correcting patient labels for NCB-PT tibial plates manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    NCB¿-PT lateral proximal 3 hole tibial plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2013·2012-11-14

    Zimmer Recalls Dynesys Stabilizing Cords Due to Labeling Discrepancies

    Zimmer, Inc. is correcting patient labels for Dynesys L.I.S. Stabilizing Cords manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Dynesys¿ L.I.S. Stabilizing cord Rx, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0269-2013·2012-11-14

    Alphatec Spine Recalls Polyaxial Screw Assemblies Due to Incorrect Length Marking

    Alphatec Spine is recalling 11 units of the TI Standard Polyaxial Screw Assembly because they were laser marked with the incorrect length of 45 MM.

    Product
    TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0247-2013·2012-11-14

    Zimmer Recalls Tibia Intramedullary Nails Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Sirus intramedullary nails for tibia due to discrepancies in reference and lot numbers.

    Product
    Sirus¿ intramedullary nail for tibia, cannulated ¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0213-2013·2012-11-14

    Zimmer Recalls Wagner SL Revision Stems for Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Wagner SL Revision Stems due to discrepancies in reference and lot numbers.

    Product
    Wagner SL Revision Stem, uncemented Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0250-2013·2012-11-14

    Sunquest Laboratory Version 7.0 Recalled for Data Integrity Errors

    Sunquest Information Systems is recalling Sunquest Laboratory version 7.0 because a software defect can cause user-defined data to be incorrectly replaced.

    Product
    Sunquest Laboratory, version 7.0 not available
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0227-2013·2012-11-14

    Zimmer Inc. Recalls Anatomical Shoulder Humeral Stems Due to Labeling Discrepancies

    Zimmer Inc. is correcting patient labels for Anatomical Shoulder Humeral stems manufactured before March 2010 due to discrepancies in reference and lot numbers.

    Product
    Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem
    Category
    Medical Device
    Distribution
    Distributed nationwide

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