BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.

    Recall: Z-2281-2016 · Initiated June 3, 2016

    Recall

    Recall Number
    Z-2281-2016
    Event Number
    74500
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 3, 2016
    Terminated
    August 1, 2018
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.

    Reason

    Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.

    Action

    Stryker notified its branches/agencies of this recall by e-mail on May 26, 2016. They were asked to quarantine the affected devices. Stryker sent a recall letter and business reply form dated June 3, 2016 to their affected customers via UPS. Stericycle will be handling the returns.

    Distribution

    Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.

    Quantity

    1,864 units