Omnia Medical: Device Recall
Recall #Z-2557-2025 · 07/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2557-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Omnia Medical
- Status
- Ongoing
- Date Initiated
- 07/15/2024
- Location
- Morgantown, WV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 units
Reason for Recall
Failure of fusion system instruments in the field.
Product Description
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Distribution Pattern
US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
Other Recalls by Omnia Medical
- Class II: Risk 07/15/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.