BEUDAMED
    FDA Recall Terminated

    Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.

    Recall: Z-0391-2010 · Initiated September 4, 2009

    Recall

    Recall Number
    Z-0391-2010
    Event Number
    53434
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 4, 2009
    Posted
    November 23, 2009
    Terminated
    June 26, 2013
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component.

    Reason

    Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.

    Action

    Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.

    Distribution

    Nationwide distribution.

    Quantity

    10 units