BEUDAMED
    FDA Recall Open, Classified

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    Recall: Z-1496-2024 · Initiated May 30, 2023

    Recall

    Recall Number
    Z-1496-2024
    Event Number
    94278
    Firm
    Synovo Production
    FEI Number
    2280596
    Product Code
    KXB
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    May 30, 2023
    Posted
    April 8, 2024
    Address
    1501 N Harbor Blvd, Ste 209, Fullerton, CA, 92835-3803

    Description

    ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566

    Reason

    Medical device components were marketed without FDA clearance and without FDA approval

    Action

    On March 21, 2024, Synovo Production issued a "Urgent Medical Device Recall" notification to affected consignees. Synovo asked consignees to take the following actions: 1. The affected devices should not be used in patients at this time; therefore, please quarantine and return all Acetabular Fixation Cups, Acetabular Bearings, and Femoral Resurfacing Cups. Please complete the enclosed recall response form detailing the affected current products that are in your possession. Be sure to follow the outlined steps: 1a) Segregate and quarantine the products; 2b) Please contact us with the return shipment carton quantity as well as the weight. We will provide a return label for shipping; 3c) Notify your consignees others within your network that may have received these devices and disseminate to them a copy of this communication. instruct them to identify and segregate any affected product from their inventory for return to Synovo. 2. Work with consignees to determine if any of the potential risks identified above from the modified devices have been experienced. Report this adverse event information directly to the manufacturer and/or FDA by completing the MedWatch Voluntary Reporting Form. 3. For any additional details see recall notification.

    Distribution

    US Nationwide distribution in the state of WA.

    Quantity

    764 units