BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.

    Recall: Z-0249-2016 · Initiated September 29, 2015

    Recall

    Recall Number
    Z-0249-2016
    Event Number
    72381
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 29, 2015
    Posted
    November 9, 2015
    Terminated
    September 23, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.

    Reason

    Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use.

    Action

    Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826. For questions regarding this recall call 201-831-5272.

    Distribution

    Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.

    Quantity

    3,444 units