Device recall
Z-0549-2025: Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to…
FDA device recall · Class II · INCIPIO DEVICES
Key facts
| Recall number (Z-number) | Z-0549-2025 |
|---|---|
| Recall event | 95653 |
| Product | Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants. |
| Product code | HWA |
| Recalling firm | INCIPIO DEVICES |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3013223655 |
At a glance
- None 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