BEUDAMED
    FDA Recall Terminated

    Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number : 5512-T-302 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.

    Recall: Z-1577-2008 · Initiated March 5, 2008

    Recall

    Recall Number
    Z-1577-2008
    Event Number
    47400
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 5, 2008
    Posted
    July 26, 2008
    Terminated
    October 25, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Triathlon TS Femoral Trial Size 3 Right Non-Sterile Catalog Number : 5512-T-302 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 Orthopedic Manual Surgical Instrument indicated for use in revision Total Knee Arthroplasty.

    Reason

    Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.

    Action

    Stryker Branches/Agencies were notifed by letter (Urgent Product Recall) on March 5, 2008. Reps were asked to examine inventory and visit hospitals that were provided with the device to retrieve product. Reps were instructed to retrieve all of the affected product lots and return them to their branch or agency warehouse for reconciliation. All products should be reconcilied on the Product Accountability Form that is attached to the letter and sent via Inter-Org Transfer back to Stryker Orthopaedics. Questions and re-orders of the product that is being returned should be directed to 201-831-5825.

    Distribution

    Nationwide Distribution --- including states of CT, NJ, PA, VA, NC, GA, FL, AL, MI, MN, IL, TX and AZ.

    Quantity

    5