BEUDAMED
    FDA Enforcement Class II Ongoing

    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

    Recall: Z-1778-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1778-2022
    Event ID
    90836
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 5, 2022
    Initiation Date
    August 24, 2022
    Classification Date
    September 23, 2022
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.

    Reason

    A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.

    Code Info

    Lot number B24694 (no UDI)

    Distribution

    Distributed to one customer located in New York.

    Quantity

    1 unit