The Recall Desk

FDA (Devices) recall action 65459

Biomet, Inc. recalled 30 products on 2013-07-17

The FDA (Devices) publishes a recall like this one as 30 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 30 pages.

Products
30
Announced
2013-07-17
Critical
0
Units
794

Why these products were recalled

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

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

26–30 of 30

  • HighFDA (Devices)··2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 37 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone to impinge on the bearing.

    Product
    REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 32 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.

    Product
    REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Distribution
    4 states