Device recall
Z-1082-2019: Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software…
FDA device recall · Class I · Brainlab AG
Key facts
| Recall number (Z-number) | Z-1082-2019 |
|---|---|
| Recall event | 82304 |
| Product | Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 ) Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. |
| Product code | HAW |
| Recalling firm | Brainlab AG |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 10, 2019 |
| 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