Device recall
Z-0662-2016: Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat…
FDA device recall · Class II · Innovasis, Inc
Key facts
| Recall number (Z-number) | Z-0662-2016 |
|---|---|
| Recall event | 72878 |
| Product | Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine. |
| Product code | NKB |
| Recalling firm | Innovasis, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2016 |
| 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