BEUDAMED
    FDA Recall Terminated

    Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Cat. no. 00999601935).

    Recall: Z-1478-06 · Initiated August 2, 2006

    Recall

    Recall Number
    Z-1478-06
    Event Number
    35943
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2006
    Posted
    August 31, 2006
    Terminated
    May 4, 2007
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Cat. no. 00999601935).

    Reason

    Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.

    Action

    Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.

    Distribution

    Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.

    Quantity

    181 of all devices