Device recall
Z-2213-2014: Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an…
FDA device recall · Class II · Brainlab AG
Key facts
| Recall number (Z-number) | Z-2213-2014 |
|---|---|
| Recall event | 68845 |
| Product | Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative… |
| Product code | HAW |
| Recalling firm | Brainlab AG |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2017 |
| 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