BEUDAMED
    FDA Recall Terminated

    The Triathlon Posteriorly Stabilized Femoral Component.

    Recall: Z-0556-05 · Initiated October 27, 2004

    Recall

    Recall Number
    Z-0556-05
    Event Number
    30379
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    NPJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2004
    Posted
    February 24, 2005
    Terminated
    May 31, 2005
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    The Triathlon Posteriorly Stabilized Femoral Component.

    Reason

    The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.

    Action

    Notification letters and Product Accountability Froms have been sent via Fedex on 10/27/2004 with return receipt.

    Distribution

    The product is distributed to its branches/agencies and to hospitals nationwide.

    Quantity

    386 UNITS