BEUDAMED
    FDA Enforcement Class II Ongoing

    TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

    Recall: Z-2557-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2557-2025
    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, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.

    Reason

    Failure of fusion system instruments in the field.

    Code Info

    Model No. 17-5A-DV45, 17-5A-DV60; UDI: 00843511122041, 00843511122058, 00843511122065.

    Distribution

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

    Quantity

    15 units