Device recall
Z-1638-2022: Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-1638-2022 |
|---|---|
| Recall event | 90678 |
| Product | Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 |
| Product code | NKB |
| Recalling firm | Aesculap Implant Systems LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180433 |
| FEI number | 2916714 |
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