Device recall
Z-0118-2022: ROSA One 3.1 Brain application The device is intended for the spatial…
FDA device recall · Class I · MEDTECH SAS
Key facts
| Recall number (Z-number) | Z-0118-2022 |
|---|---|
| Recall event | 88746 |
| Product | ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries. |
| Product code | HAW |
| Recalling firm | MEDTECH SAS |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K182417, K200511 |
| FEI number | 3009185973 |
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