The Recall Desk

Archive

June 2013 recalls

533 recalls were announced in June 2013.

What the numbers show

Critical
24
Severe
176
High
192
Moderate
108
Low
33

Of the 533 recalls this month scored against our rubric, 5% are Critical, 33% are Severe.

Which agencies issued them

501–533 of 533

  • ModerateFDA (Devices)·Z-1396-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancellous bone screw,25mm Co-Cr cancellous bone screw,30mm Co-Cr cancellous bone screw,35mm Co-Cr cancellous bone screw,40mm Variety of hip and knee implants and instruments, multiple uses.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1390-2013·2013-06-05

    Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1392-2013·2013-06-05

    Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision

    Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported breakage during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1413-2013·2013-06-05

    Spinal Solutions Recalls 50 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 55 units of 50 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    50 mm Rod, Item #BG1650 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1388-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 164 units of the Aliquot Plunger Delivery System because the catheter may break during removal from the needle.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1382-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Missing Instructions

    Orthopedic Alliance LLC is recalling 21 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral head, long, ¿26mm, +6mm Femoral head, X-long, ¿26mm, +9mm Femoral head, ¿28mm, -3mm Femoral head, ¿28mm, +0mm Femoral head, ¿28mm, +5mm Femoral head, ¿28mm, +10mm Femoral head, ¿32mm, -3mm Femora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1378-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Implants

    Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, cemented, #2, left 2103-1320 Femoral component, CR, cemented, #3, left 2103-1330 Femoral component, CR, cemented, #4, left 2103-1340 Femoral component, CR, cemented, #5, left 2103-1350 Femoral compone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2013·2013-06-05

    Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk

    Stryker Orthobiologics is recalling five Aliquot Reamer units because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1418-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions

    Spinal Solutions is recalling loaner bins and sterilization trays for spinal implants because directions for use and surgical techniques were not provided to every physician.

    Product
    Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 78 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1408-2013·2013-06-05

    Merit Medical Recalls Performa Cardiac Multipacks Due to Tip Shape Variation

    Merit Medical Systems is recalling specific lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.

    Product
    Merit Medical PerfOrma Anglographic Catheter 5F Multipack Product Usage: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins Due to Missing Surgical Instructions

    Spinal Solutions is recalling 35 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 x 11 x 8mm 7 deg 14 x 11 x 9mm 7 deg 14 x 11 x 10mm 7 deg 14 x 11 x 11mm 7 deg 14 x 11 x 12mm 7 deg Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-496-2013·2013-06-05

    Teva Recalls Seasonale Tablets Due to Impurity Detection

    Teva Pharmaceuticals is recalling Seasonale tablets because testing detected an impurity called N-Butyl-Benzene Sulfonamide.

    Product
    Seasonale(R) (Levonorgestrel/Ethinyl Estradiol Tablets), 0.15 mg/0.03 mg, 3 extended-cycle tablet dispensers, 91 tablets each, Rx only, TEVA Women Health, Inc., Subsidiary of TEVA Pharmaceuticals USA, Inc., Sellersville, PA NDC 51285-058-66
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1389-2013·2013-06-05

    Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage

    Stryker Orthobiologics is recalling 411 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.

    Product
    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1415-2013·2013-06-05

    Spinal Solutions Recalls Loaner Bins and Sterilization Trays for Missing Instructions

    Spinal Solutions, LLC is recalling 56 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has de
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1456-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling specific fruit cups because the serving size was updated but the nutrition facts were not.

    Product
    Meijer Mandarin Oranges in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-1381-2013·2013-06-05

    Orthopedic Alliance Recalls Loaner Bin and Sterilization Trays for Documentation Issues

    Orthopedic Alliance LLC is recalling 30 units of loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.

    Product
    U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads porous coated, ¿46mm U2 Acetabular cup, Ti beads porous coated, ¿48mm U2 Acetabular cup, Ti beads porous coated, ¿50mm U2 Acetabular cup, Ti beads porous coated, ¿52mm U2 Acetabular cup, Ti beads po
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-498-2013·2013-06-05

    Aurobindo Recalls Lisinopril Tablets Due to Labeling Error

    Aurobindo Pharma USA Inc is recalling specific lots of Lisinopril 30 mg tablets because the label displays the incorrect strength on the side panel.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1429-2013·2013-06-05

    Intuitive Surgical da Vinci Si Surgeon Console Labeling Clarification

    Intuitive Surgical is clarifying labeling and operating procedures for the da Vinci Si Surgeon Console to ensure accurate control of endoscopic instruments.

    Product
    da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1412-2013·2013-06-05

    Spinal Solutions Recalls 40 mm Rods Due to Missing Surgical Instructions

    Spinal Solutions is recalling 63 units of 40 mm Rods because directions for use and surgical techniques were not provided to every physician.

    Product
    40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has cr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1455-2013·2013-06-05

    Meijer Fruit Cups Recalled for Nutrition Labeling Errors

    Meijer Distribution is recalling diced pears, peaches, and mandarin oranges in fruit juice 8 oz cups because the nutrition facts panel reflects the wrong serving size.

    Product
    Meijer Diced Peaches in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-1426-2013·2013-06-05

    Intuitive Surgical Recalls Unapproved da Vinci Thyroidectomy Promotional Literature

    Intuitive Surgical is recalling promotional literature for the da Vinci Surgical System's thyroidectomy indication because the use was not approved with a 510(k) change.

    Product
    Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (op
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1454-2013·2013-06-05

    Meijer Diced Pears Recalled for Nutrition Labeling Error

    Meijer Distribution is recalling Diced Pears in Fruit Juice 8oz cups because the nutrition facts label reflects the wrong serving size.

    Product
    Meijer Diced Pears in Fruit Juice 8oz cup
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·13V239000·2013-06-04

    Chrysler Recalls 2012 Dodge Ram Trucks Due to Front Axle Fracture Risk

    Chrysler is recalling 5,622 model year 2012 Dodge Ram 4500 and 5500 trucks because a welding defect may cause the front drive shaft to fracture, potentially leading to a loss of motive power and increased crash risk.

    Product
    DODGE — DODGE RAM 5500, RAM 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V234000·2013-06-04

    Chrysler Recalls 2012-2013 Jeep Wranglers for Transmission Fluid Leak Risk

    Chrysler is recalling 2012-2013 Jeep Wranglers with 3.6L engines and automatic transmissions because a power steering line may wear a hole in the transmission oil cooler line, causing fluid loss.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V233000·2013-06-04

    Chrysler Recalls Jeep Compass and Patriot for Airbag Software Error

    Chrysler is recalling 2010-2012 Jeep Compass and Patriot vehicles because a software error may prevent side airbags and seatbelt pre-tensioners from deploying in a crash.

    Product
    JEEP — JEEP COMPASS, PATRIOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V240000·2013-06-04

    Chrysler Recalls 2013 Ram Trucks for Headlight Shutter Defect

    Chrysler is recalling 2013 Ram 2500 and 3500 trucks because headlamp shutters may malfunction in high-beam mode, potentially blinding oncoming traffic.

    Product
    RAM — RAM 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V236000·2013-06-04

    Mercedes-Benz Recalls 2013 SLK250 and SLK350 for Airbag System Defect

    Mercedes-Benz is recalling 2013 SLK250 and SLK350 vehicles because the occupant classification system may fail to detect light passengers, potentially deactivating the airbag.

    Product
    MERCEDES-BENz — MERCEDES-BENz, MERCEDES-BENZ SLK250, SLK350
    Category
    Vehicle
    Distribution
    Distributed nationwide

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