BEUDAMED
    FDA Recall Terminated

    Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.

    Recall: Z-0719-04 · Initiated February 10, 2004

    Recall

    Recall Number
    Z-0719-04
    Event Number
    28405
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 10, 2004
    Posted
    July 20, 2004
    Terminated
    June 9, 2004
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Restoration Hip system Cylindrical Distal Extension. Catalog Numbers 1212-3105, 1212-3115, 1212-3125, and 1212-3195. Sizes 12.5mm, 11.5mm, 19.5mm, and 10.5mm extensions.

    Reason

    The Cylindrical Distal Extensions were incorrectly coded and packaged.

    Action

    Stryker Orthopaedics sent product recall letters to the Branch/Agency involved on 2/10/2004 via FedEx. International distributor was sent notification on 2/10/2004.

    Distribution

    The 9 units were sent out to 2 US branch/agents and one international distributor.

    Quantity

    20