Device recall
Z-2557-2025: TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled…
FDA device recall · Class II · Omnia Medical
Key facts
| Recall number (Z-number) | Z-2557-2025 |
|---|---|
| Recall event | 97402 |
| Product | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwdrivers, Sizes 30 degree, 45 degree, and 60 degree angles. |
| Product code | OVD |
| Recalling firm | Omnia Medical |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K203207 |
| FEI number | 3010560653 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database