BEUDAMED
    FDA Enforcement Class II Ongoing

    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

    Recall: Z-2556-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2556-2025
    Event ID
    97402
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Omnia Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 17, 2025
    Initiation Date
    July 15, 2024
    Classification Date
    September 11, 2025
    Address
    6 Canyon Rd Ste 300, N/A, Morgantown, WV, 26508-9232, United States

    Description

    TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.

    Reason

    Failure of fusion system instruments in the field.

    Code Info

    Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.

    Distribution

    US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.

    Quantity

    15 units