Device recall
Z-0644-2018: Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally…
FDA device recall · Class II · Innovasis, Inc
Key facts
| Recall number (Z-number) | Z-0644-2018 |
|---|---|
| Recall event | 78946 |
| Product | Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic deformities of the thoracic, lumbar, and sacral spine: |
| Product code | NKB |
| Recalling firm | Innovasis, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 27, 2018 |
| 510(k) numbers | K102248 |
| 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