Recall Z-2556-2025
Omnia Medical · initiated July 15, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
Codes / lots: Model No. 17-5A-AWL3, 17-5A-AWL4, 17-5A-AWL5; UDI: 00843511113056, 00843511122287, 00843511122294.
Reason for recall
Failure of fusion system instruments in the field.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2556-2025
- Initiated
- July 15, 2024
- Posted by FDA
- September 11, 2025
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 15 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
- Recalling firm
- Omnia Medical, Morgantown, WV
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2557-2025 Class II | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers…Failure of fusion system instruments in the field. | 07/15/2024Open, Classified |