BEUDAMED
    FDA Recall Terminated

    Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.

    Recall: Z-0399-2007 · Initiated December 4, 2006

    Recall

    Recall Number
    Z-0399-2007
    Event Number
    37024
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 4, 2006
    Posted
    February 8, 2007
    Terminated
    February 21, 2007
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.

    Reason

    A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.

    Action

    Notification letters and Product Accountability forms were sent on 12/8/2006 by Federal Express with return receipt.

    Distribution

    Nationwide and Canada.

    Quantity

    23 units