BEUDAMED
    FDA Recall Terminated

    Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland

    Recall: Z-0475-2007 · Initiated November 28, 2006

    Recall

    Recall Number
    Z-0475-2007
    Event Number
    36973
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KWL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 28, 2006
    Posted
    January 13, 2007
    Terminated
    May 8, 2007
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Howmedica Hip Fracture Stem System No. 3.5 Femoral Component Uses No. 3 Fenestrated Plus Sterile REF Catalogue #6942-0-035 Made in Ireland

    Reason

    Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

    Action

    Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.

    Distribution

    Nationwide

    Quantity

    126 units