Device recall
Z-0480-2016: Synaptive Medical BrightMatter Navigator System (Guide System). Part number…
FDA device recall · Class II · Synaptive Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0480-2016 |
|---|---|
| Recall event | 72747 |
| Product | Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The Guide system is comprised of a cart labelled SYN-0024 and a cart labelled SYN-0025, Operator Cart. A planning and intraoperative guidance system to enable open and percutaneous computer assisted surgery. The… |
| Product code | HAW |
| Recalling firm | Synaptive Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 4, 2016 |
| 510(k) numbers | K142024 |
| FEI number | 3012075008 |
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