BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-2462-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2462-2026
    Event ID
    99080
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2026
    Initiation Date
    May 19, 2026
    Classification Date
    June 17, 2026
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    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).

    Code Info

    Part Number: 5521-B-400. UDI: (01)07613327026061(17)260921(10) TYX7OB. Lot Number: TYX7OB.

    Distribution

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

    Quantity

    7 units