BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

    Recall: Z-0140-2023 · Reported November 2, 2022

    Enforcement

    Recall Number
    Z-0140-2023
    Event ID
    90965
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Wright Medical Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    October 27, 2022
    Address
    1023 Cherry Rd, N/A, Memphis, TN, 38117-5423, United States

    Description

    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4

    Reason

    The tibial tray lock detail is oversized (larger than specification).

    Code Info

    GTIN 00840420124159, Lot Code: 1725563

    Distribution

    US Nationwide distribution in the state of New York.

    Quantity

    1 unit