BEUDAMED
    FDA Recall Terminated

    Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

    Recall: Z-2079-2008 · Initiated March 17, 2005

    Recall

    Recall Number
    Z-2079-2008
    Event Number
    48199
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 17, 2005
    Posted
    September 16, 2008
    Terminated
    September 24, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.

    Reason

    Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

    Action

    The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005

    Distribution

    The one unit was distributed to an International Stryker branch.

    Quantity

    1 unit