The Recall Desk

FDA (Devices) recall action 76179

Biomet U.K., Ltd. recalled 24 products on 2017-03-01

The FDA (Devices) publishes a recall like this one as 24 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 24 pages.

Products
24
Announced
2017-03-01
Critical
0
Units
1,728

Why these products were recalled

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–24 of 24

  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Knee System Tibial Resector Body Tubes and Guides due to potential alumina inclusions that could cause the instruments to crack or separate.

    Product
    Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 1 instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • SevereFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Partial Knee Trial Trays Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System trial trays due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • SevereFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System Femoral Slap Hammers due to potential alumina inclusions that could cause the instruments to crack or separate.

    Product
    Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions

    Biomet U.K. is recalling Oxford Partial Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Oxford Knee Instruments Recalled for Material Inclusions

    Biomet is recalling Oxford Knee instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • SevereFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Partial Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states
  • HighFDA (Devices)··2017-03-01

    Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

    Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

    Product
    Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
    Category
    Distribution
    14 states