BEUDAMED
    FDA Enforcement Class II Ongoing

    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

    Recall: Z-0214-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0214-2024
    Event ID
    93144
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Corin Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 8, 2023
    Initiation Date
    October 13, 2023
    Classification Date
    November 2, 2023
    Address
    Unit 1-57-8, Corinium Centre, Cirencester, N/A, N/A, United Kingdom

    Description

    Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty

    Reason

    Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

    Code Info

    UDI/DI 05055343872505, Lot Number 532405.

    Distribution

    US: MI, TX, IL

    Quantity

    1 units