BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    Recall: Z-2130-2013 · Reported September 4, 2013

    Enforcement

    Recall Number
    Z-2130-2013
    Event ID
    65902
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 4, 2013
    Initiation Date
    July 2, 2013
    Classification Date
    August 29, 2013
    Termination Date
    April 27, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002, United States

    Description

    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.

    Reason

    Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.

    Code Info

    Catalog #6541-2-609 All lot codes

    Distribution

    Nationwide Distribution

    Quantity

    10,537 units