Device recall
Z-2108-2018: ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a…
FDA device recall · Class II · MEDTECH SAS
Key facts
| Recall number (Z-number) | Z-2108-2018 |
|---|---|
| Recall event | 80061 |
| Product | ROSA(TM) Robotized Stereotactic Assistant, Version 2.5 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan… |
| Product code | HAW |
| Recalling firm | MEDTECH SAS |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2020 |
| 510(k) numbers | K101791 |
| 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