BEUDAMED
    FDA Recall Terminated

    Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left , sterile, Zimmer, Warsaw, IN; REF 00-5964-017-51.

    Recall: Z-1522-2009 · Initiated April 17, 2009

    Recall

    Recall Number
    Z-1522-2009
    Event Number
    52003
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    NJL
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 17, 2009
    Posted
    June 25, 2009
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer NexGen Complete Knee Solution Legacy Knee- Posterior Stabilized LPS-FLEX Femoral Component Option Size G Left , sterile, Zimmer, Warsaw, IN; REF 00-5964-017-51.

    Reason

    The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.

    Action

    Consignees were notified by phone beginning on 4/17/09 and email and letter notifications were sent on 4/22/09. A dear surgeon letter entitled Urgent: Medical Device Recall, dated April 28, 2009, is being sent to implanting surgeons recommending patient monitoring. Consignees are to return the response form indicating their receipt of the notification. Questions or concerns should be directed to (800) 846-4637 or www.zimmer.com.

    Distribution

    Worldwide Distribution -- USA including states of Arizona, California, Colorado, Hawaii, Illinois, Indiana, Michigan, Minnesota, Mississippi, New Jersey, New Mexico, New York, Ohio, Oregon, and Pennsylvania and country of Canada.

    Quantity

    21