BEUDAMED
    FDA Recall Terminated

    Long Length Dyax Nail.

    Recall: Z-0256-06 · Initiated September 7, 2004

    Recall

    Recall Number
    Z-0256-06
    Event Number
    31986
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    NDH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 7, 2004
    Posted
    December 1, 2005
    Terminated
    October 3, 2006
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Long Length Dyax Nail.

    Reason

    Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.

    Action

    The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.

    Distribution

    The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.

    Quantity

    4