BEUDAMED
    FDA Recall Terminated

    Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.

    Recall: Z-0058-06 · Initiated August 11, 2005

    Recall

    Recall Number
    Z-0058-06
    Event Number
    33035
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 11, 2005
    Posted
    October 15, 2005
    Terminated
    August 15, 2007
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.

    Reason

    The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.

    Action

    The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.

    Distribution

    The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.

    Quantity

    8 units