Device recall
Z-0320-2018: Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-0320-2018 |
|---|---|
| Recall event | 78715 |
| Product | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left |
| Product code | HAW |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2020 |
| 510(k) numbers | K070106 |
| FEI number | 3002619595 |
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