TiBrid Stand Alone Intervertebral Body Fusion Device — Class II medical device recall Z-2557-2025
Ongoing recall by Omnia Medical, reported 2025-09-17, distributed nationwide. Failure of fusion system instruments in the field.
| Recall number | Z-2557-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Omnia Medical, Morgantown, WV, United States |
| Recall initiated | 2024-07-15 |
| Classified | 2025-09-11 |
| Reported by FDA | 2025-09-17 |
| Distributed | Nationwide (US) |
| Quantity | 15 units |
| UPC / GTIN / UDI-DI | 00843511122041, 00843511122058, 00843511122065 |
| Model numbers | 17-5A-DV45, 17-5A-DV60 |
Product
TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles.
Reason for recall
Failure of fusion system instruments in the field.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2557-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.