BEUDAMED
    FDA Recall Terminated

    Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.

    Recall: Z-1381-2008 · Initiated February 8, 2005

    Recall

    Recall Number
    Z-1381-2008
    Event Number
    47219
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 8, 2005
    Posted
    July 16, 2008
    Terminated
    July 16, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.

    Reason

    Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.

    Action

    Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.

    Distribution

    Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.

    Quantity

    7 units