BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0273-2023 · Initiated October 31, 2022

    Recall

    Recall Number
    Z-0273-2023
    Event Number
    91039
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 31, 2022
    Posted
    November 21, 2022
    Terminated
    January 12, 2024

    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.

    Action

    Corin Group notified consignees on 10/31/2022 via letter titled "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to examine inventory, quarantine affected product, arrange for its return, and notify all facilities/personnel if devices were further distributed. Consignees were also asked to complete and return the acknowledgement form by e-mail to [email protected]. For all questions on this notice, please contact me at +1 772-321-2478 or by e-mail to [email protected].

    Distribution

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

    Quantity

    4 devices