Drug recall
TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60…
FDA recall event 97402 · Class II · Omnia Medical
Key facts
| Event ID | 97402 |
|---|---|
| Recall numbers | Z-2556-2025, Z-2557-2025 |
| Recalling firm | Omnia Medical |
| Product type | Devices |
| Products | TiBrid Stand Alone Intervertebral Body Fusion Device, SA Angled Punch Awl, Sizes: 30 degree, 45 degree and 60 degree., TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failure of fusion system instruments in the field. |
| Initiation date | Jul 15, 2024 |
| Report date | Sep 17, 2025 |
| City | Morgantown |
| State | WV |
| Country | United States |
| FEI number | 3010560653 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: