BEUDAMED
    FDA Recall Terminated

    Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.

    Recall: Z-1618-2009 · Initiated May 15, 2009

    Recall

    Recall Number
    Z-1618-2009
    Event Number
    52191
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    May 15, 2009
    Posted
    July 15, 2009
    Terminated
    April 5, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures.

    Reason

    The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.

    Action

    Stryker Orthopaedics issued an "Urgent Product Correction" notice dated May 15, 2009 via Federal Express addressed to Branch/Agency Manager/Quality Contact informing them of the affected device. The letter outlined instructions for correction and requested consignees to complete and return a Product Correction Acknowledgment Form by fax to 1-201-831-6069. Questions can be directed to Colleen O'Meara, Manager, Divisional Regulatory Reporting at 201-831-5970.

    Distribution

    Worldwide Distribution -- US and Canada.

    Quantity

    27