Device recall
Z-2067-2014: Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x…
FDA device recall · Class II · Innovasis, Inc
Key facts
| Recall number (Z-number) | Z-2067-2014 |
|---|---|
| Recall event | 68781 |
| Product | Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. |
| Product code | NKB |
| Recalling firm | Innovasis, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2014 |
| 510(k) numbers | K102248, K140238 |
| 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