BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0214-2024 · Initiated October 13, 2023

    Recall

    Recall Number
    Z-0214-2024
    Event Number
    93144
    Firm
    Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    October 13, 2023
    Posted
    November 2, 2023

    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.

    Action

    Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.

    Distribution

    US: MI, TX, IL

    Quantity

    1 units