Device recall
Z-2153-2017: Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*…
FDA device recall · Class II · Innovasis, Inc
Key facts
| Recall number (Z-number) | Z-2153-2017 |
|---|---|
| Recall event | 77206 |
| Product | Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and… |
| Product code | KWQ |
| Recalling firm | Innovasis, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2017 |
| 510(k) numbers | K061147 |
| FEI number | 3004719693 |
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