Device recall
Z-2615-2025: Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model…
FDA device recall · Class II · ORTOMA AB
Key facts
| Recall number (Z-number) | Z-2615-2025 |
|---|---|
| Recall event | 97416 |
| Product | Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter… |
| Product code | OLO |
| Recalling firm | ORTOMA AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232140, K250086 |
| FEI number | 3014411622 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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