Device recall
Z-0176-2021: Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage…
FDA device recall · Class II · Bien-Air Surgery Sa
Key facts
| Recall number (Z-number) | Z-0176-2021 |
|---|---|
| Recall event | 86419 |
| Product | Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones. |
| Product code | ERL |
| Recalling firm | Bien-Air Surgery Sa |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K792159 |
| 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