BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    Recall: Z-1385-2023 · Reported April 19, 2023

    Enforcement

    Recall Number
    Z-1385-2023
    Event ID
    91913
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 19, 2023
    Initiation Date
    March 10, 2023
    Classification Date
    April 12, 2023
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States

    Description

    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

    Reason

    Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

    Code Info

    GTIN 00848486003746, Lot Number 26270421

    Distribution

    U.S., Netherlands, Japan, China, India, Korea, and Australia.

    Quantity

    52 units