Device recall
Z-1190-2016: Instinct Java System (IFU reference: 046WAN0000T). Stabilizes one or more…
FDA device recall · Class II · Zimmer Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1190-2016 |
|---|---|
| Recall event | 73363 |
| Product | Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue. |
| Product code | NKB |
| Recalling firm | Zimmer Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 11, 2016 |
| 510(k) numbers | K111301, K113270, K122592, K123552 |
| FEI number | 1000115775 |
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