Device recall
Z-1391-2016: X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical…
FDA device recall · Class II · X-NAV Technologies, LLC
Key facts
| Recall number (Z-number) | Z-1391-2016 |
|---|---|
| Recall event | 73544 |
| Product | X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures. |
| Product code | PLV |
| Recalling firm | X-NAV Technologies, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 1, 2016 |
| 510(k) numbers | K150222 |
| FEI number | 3011764595 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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