BEUDAMED
    FDA Recall Open, Classified

    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500

    Recall: Z-1237-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1237-2022
    Event Number
    90241
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 30, 2022
    Posted
    June 3, 2022
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Triathlon Tritanium Tibial Component (Size 6); Catalog Number 5536-B-600 Triathlon Tritanium Tibial Component (Size 5); Catalog Number 5536-B-500

    Reason

    Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

    Action

    On March 30, 2022, the firm sent Urgent Medical Device Recall letters to affected customers. Customers were instructed to immediately identify, quarantine, and discontinue use of any affected devices in their facility. Customers should return the devices back to Stryker. If you have any questions or concerns regarding this recall, please contact Customer Service at (201) 831-5000. For questions pertaining to the recall, email [email protected]. ***Updated 6/6/22*** On June 6, 2022, the firm sent an updated letter to affected customers. The update letter includes the hazards, harms, and risk mitigation.

    Distribution

    Worldwide distribution - US Nationwide in the states of AL, CA, CO, ID, IN, KS, MI, NV, PA, TN, WA, and WV. The countries of UK and Poland.

    Quantity

    22 units (12 US; 10 OUS)