Device recall
Z-0179-2021: Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product…
FDA device recall · Class II · Bien-Air Surgery Sa
Key facts
| Recall number (Z-number) | Z-0179-2021 |
|---|---|
| Recall event | 86419 |
| Product | Stryker Instruments REF 5452-007-000 SN ******* S2 MINI FOOT Pedal - Product Usage: The S2 Mini Drill System has been designed for the light drilling of bones as part of surgical operations such as stapedotomy or ossiculoplasty. The S2 Mini Drill System consists of a foot pedal and a drill, with an… |
| 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