Omnia Medical: Device Recall
Recall #Z-2556-2025 · 07/15/2024
Class II: Risk
Recall Details
- Recall Number
- Z-2556-2025
- 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, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
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.