BEUDAMED
    FDA Recall Terminated

    Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.

    Recall: Z-1814-2008 · Initiated November 8, 2005

    Recall

    Recall Number
    Z-1814-2008
    Event Number
    48096
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 8, 2005
    Posted
    September 11, 2008
    Terminated
    May 13, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.

    Reason

    Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.

    Action

    Consignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.

    Distribution

    Worldwide Distribution

    Quantity

    8 units