Device recall
Z-0180-2021: Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product…
FDA device recall · Class II · Bien-Air Surgery Sa
Key facts
| Recall number (Z-number) | Z-0180-2021 |
|---|---|
| Recall event | 86419 |
| Product | Entellus Medical REF SSA-102 SN ******* Shaver System Foot Pedal - Product Usage: The Entellus Medical Shaver System has been designed for shaping bone and for the resection of soft and hard tissues as part of surgical procedures in the areas of otorhinolaryngology. |
| 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