Class II — Omnia Medical
| Recalling firm | Omnia Medical |
|---|---|
| Registered facility | Omnia Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Failure of fusion system instruments in the field. |
| Product | TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree. |
| Quantity | 15 units |
| Distribution | US Nationwide distribution in the states of AZ, CA, NJ, NV, OK & WA. |
| Initiated | 2024-07-15 |
| Classified | 2025-09-11 |
| Recall number | Z-2556-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Omnia Medical (Z-2556-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97402/
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