BEUDAMED
    FDA Recall Terminated

    OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    Recall: Z-2054-2008 · Initiated March 9, 2005

    Recall

    Recall Number
    Z-2054-2008
    Event Number
    47899
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 9, 2005
    Posted
    September 16, 2008
    Terminated
    September 24, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

    Reason

    The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.

    Action

    Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.

    Distribution

    Worldwide

    Quantity

    865 units