BEUDAMED
    FDA Recall Terminated

    Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325

    Recall: Z-1241-2007 · Initiated October 17, 2006

    Recall

    Recall Number
    Z-1241-2007
    Event Number
    38814
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 17, 2006
    Posted
    September 21, 2007
    Terminated
    July 7, 2009
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325

    Reason

    Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

    Action

    Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.

    Distribution

    Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.

    Quantity

    3 total, 2 in USA