Device recall
Z-0623-2018: The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of…
FDA device recall · Class II · Aesculap Implant Systems LLC
Key facts
| Recall number (Z-number) | Z-0623-2018 |
|---|---|
| Recall event | 79092 |
| Product | The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial Surgery. |
| Product code | HBB |
| Recalling firm | Aesculap Implant Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2019 |
| FEI number | 2916714 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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