BEUDAMED
    FDA Recall Open, Classified

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    Recall: Z-2069-2025 · Initiated May 23, 2025

    Recall

    Recall Number
    Z-2069-2025
    Event Number
    97006
    Firm
    CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom
    FEI Number
    3002806725
    Product Code
    JWH
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 23, 2025
    Posted
    July 2, 2025

    Description

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    Reason

    Investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches.

    Action

    Corin Group notified US agents informally via email on 05/23/2025 and informed them of an investigation and affected inventory to quarantine. A formal notification was sent to consignees on about 06/02/2025. Consignees were instructed to identify any affected units on hand and quarantine them, return them to Corin and notify all affected parties who handled the product. Consignees were also requested to complete and return the acknowledgement form. If product was further distributed, Corin requested contact information to contact those customers.

    Distribution

    US Nationwide distribution in the states of CA, CO, FL, IL, OK, TX, UT.

    Quantity

    341 units