BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1163-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1163-2017
    Event ID
    76179
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet U.K., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 5, 2016
    Classification Date
    February 22, 2017
    Termination Date
    June 30, 2018
    Address
    Waterton Industrial Estate, N/A, Bridgend South Wales, N/A, N/A, United Kingdom

    Description

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

    Reason

    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.

    Code Info

    Item: 32-420734, Lots: ZB160501, ZB160601, ZB160802

    Distribution

    Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS

    Quantity

    72 units in total