Device recall
Z-0177-2021: Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO…
FDA device recall · Class II · Bien-Air Surgery Sa
Key facts
| Recall number (Z-number) | Z-0177-2021 |
|---|---|
| Recall event | 86419 |
| Product | Bien-Air Surgery REF 1600517-001 SN ******* MULTIFUNCTION PEDAL OSSEODUO - Product Usage: Product Usage: intended to convert electrical energy to mechanically drive attachment, microsaws, shaver blades and burs, burs and perforator tools for cutting and shaping bone including spine and cranium. |
| Product code | ERL |
| Recalling firm | Bien-Air Surgery Sa |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K083720 |
| 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