BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2556-2025 · Initiated July 15, 2024

    Recall

    Recall Number
    Z-2556-2025
    Event Number
    97402
    FEI Number
    3010560653
    Product Code
    OVD
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    July 15, 2024
    Posted
    September 11, 2025
    Address
    Omnia Medical 6 Canyon Rd, Ste 300, Morgantown, WV, 26508-9232

    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.

    Action

    Consignees were called on or around 8/1/2024 to notify them of this recall of instruments. Affected instruments were to be sent back to Omnia Medical and replaced with instruments that underwent rework in the form of design changes aimed at increasing their durability.

    Distribution

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

    Quantity

    15 units