BEUDAMED
    FDA Recall Terminated

    Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)

    Recall: Z-0170-06 · Initiated October 4, 2005

    Recall

    Recall Number
    Z-0170-06
    Event Number
    33895
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 4, 2005
    Posted
    November 18, 2005
    Terminated
    May 4, 2006
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)

    Reason

    Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.

    Action

    The product recall will extend to all branches.agencies and hospitals that have received the product.

    Distribution

    nationwide

    Quantity

    34,839 units