Device recall
Z-0172-2020: Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a…
FDA device recall · Class I · MEDTECH SAS
Key facts
| Recall number (Z-number) | Z-0172-2020 |
|---|---|
| Recall event | 83665 |
| Product | Rosa Brain 3.0, Model No. ROSA 3.0. The device is delivered assembled in a wooden case and protected with plastic bubble and plastic film. Seals are put on the crate. The product is not shipped sterile. The device is intended for the spatial positioning and orientation of instrument holders or tool… |
| Product code | HAW |
| Recalling firm | MEDTECH SAS |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 2, 2021 |
| 510(k) numbers | K151359, K172444 |
| 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