BEUDAMED
    FDA Recall Open, Classified

    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

    Recall: Z-2462-2026 · Initiated May 19, 2026

    Recall

    Recall Number
    Z-2462-2026
    Event Number
    99080
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MBH
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 19, 2026
    Posted
    June 17, 2026
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.

    Reason

    Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

    Action

    Stryker notified consignees on about 05/19/2026 via letter sent using FedEx 2-day service. Consignees were instructed to inform users of the Urgent Medical Device Recall and forward the notice to all individuals who need to be made aware or organizations who have consigned product, immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are on hand, and complete and return the provided Urgent Medical Device Recall Business Reply Form.

    Distribution

    US Nationwide distribution in the states of AZ, CA, GA, MI, NC, NJ, NY, WV.

    Quantity

    7 units