BEUDAMED
    FDA Enforcement Class II Terminated

    REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 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 tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    Recall: Z-1706-2013 · Reported July 17, 2013

    Enforcement

    Recall Number
    Z-1706-2013
    Event ID
    65459
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 17, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    July 11, 2013
    Termination Date
    July 17, 2014
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 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 tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

    Reason

    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.

    Code Info

    M321580 , M619780, M492960, M656960, M969120 , M444790 6

    Distribution

    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

    Quantity

    30