BEUDAMED
    FDA Recall Terminated

    Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

    Recall: Z-0467-2007 · Initiated November 7, 2006

    Recall

    Recall Number
    Z-0467-2007
    Event Number
    36871
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MBB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2006
    Posted
    January 10, 2007
    Terminated
    February 28, 2007
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

    Reason

    The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.

    Action

    A recall notification was sent by Federal Express on 11/7/06. The firm will follow-up with telephone calls and follow-up letters as necessary.

    Distribution

    Nationwide

    Quantity

    813 units