BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.

    Recall: Z-2377-2016 · Initiated June 23, 2016

    Recall

    Recall Number
    Z-2377-2016
    Event Number
    74634
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 23, 2016
    Terminated
    March 27, 2019
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replacement (PKR) system. The use of the handles in Primary TKA is optional and may be used to: (1) Assist in stabilizing the Triathlon Femoral Sizer, (2) Aid in stabilization during use and removal of the Triathlon 4:1 Cutting Block and (3) Aid in assembly of the Anterior MIS Distal Resection Guide to the Anterior Skim Cut Guide. Per the Triathlon PKR surgical protocol, the handle is required for a PKR surgery and is used to: (1) Assemble and disassemble the Femoral Trial Drill Guide into the Femoral Trial and (2) Remove the Peg Trial from the Femoral Trial.

    Reason

    Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved potentially resulting in disassociation from the instrument.

    Action

    Stryker sent an Urgent Product Recall letter dated June 24, 2016 to Branches/Agencies by e-mail and Business Reply Forms was sent to Branches/Agents/Hospital Risk Management via UPS (with return receipt) on June 24, 2016. The letter identified the affected product, problem and actions to be taken. For questions call (201) 831-6693.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    12,469 units