BEUDAMED
    FDA Recall Terminated

    Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.

    Recall: Z-0241-06 · Initiated November 22, 2004

    Recall

    Recall Number
    Z-0241-06
    Event Number
    31985
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    NDH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 22, 2004
    Posted
    December 1, 2005
    Terminated
    October 3, 2006
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.

    Reason

    The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.

    Action

    Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.

    Distribution

    The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.

    Quantity

    19