Device recall
Z-0178-2021: Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product…
FDA device recall · Class II · Bien-Air Surgery Sa
Key facts
| Recall number (Z-number) | Z-0178-2021 |
|---|---|
| Recall event | 86419 |
| Product | Bien-Air Surgery REF 1600686-001 SN ******* OSSEOSTAP Footcontrol - Product Usage: an active medical device that convert electrical energy into mechanical rotation to a but during Ear, Nose and Throat (ENT) surgery. |
| Product code | ERL |
| Recalling firm | Bien-Air Surgery Sa |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K143492 |
| FEI number | 3003800209 |
At a glance
- 1–9 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