TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree.
FDA device recall Z-2556-2025 · posted 2025-09-11 · Open, Classified
Recall details
- Recalling firm
- Omnia Medical
- Reason for recall
- Failure of fusion system instruments in the field.
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OVD
- Quantity affected
- 15 units
- Distribution
- US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA.
- Date initiated
- 2024-07-15
- Date posted
- 2025-09-11
- Location
- Morgantown, WV
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Omnia Medical TiBrid-SA (K203207) | Omnia Medical, LLC | 2020-12-23 |