BEUDAMED
    FDA Enforcement Class II Terminated

    Unity Total Knee System. Used for knee prosthesis in total knee replacement

    Recall: Z-0273-2023 · Reported November 30, 2022

    Enforcement

    Recall Number
    Z-0273-2023
    Event ID
    91039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Corin Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    November 30, 2022
    Initiation Date
    October 31, 2022
    Classification Date
    November 21, 2022
    Termination Date
    January 12, 2024
    Address
    Unit 1-57-8, Corinium Centre, Cirencester, N/A, N/A, United Kingdom

    Description

    Unity Total Knee System. Used for knee prosthesis in total knee replacement

    Reason

    The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.

    Code Info

    Model Number: 112.040.06; Lot Number: 504337

    Distribution

    Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.

    Quantity

    4 devices