BEUDAMED
    FDA Recall 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 · Initiated July 2, 2013

    Recall

    Recall Number
    Z-2130-2013
    Event Number
    65902
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    GDJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 2, 2013
    Posted
    August 29, 2013
    Terminated
    April 27, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    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.

    Action

    Stryker Orthopaedics sent an Urgent Medical Device Correction letter dated July 2, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by t he customers. Customers are advised of the issue, potential hazards and risk mitigation factors. Customers are asked to complete the attached form and fax to 855-251-3635. Any questions should be directed to (201) 972-2100. All letters included a Product Correction Bulletin.

    Distribution

    Nationwide Distribution

    Quantity

    10,537 units