Device recall
Z-1351-2018: Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use…
FDA device recall · Class II · W & H DentalWerk Burmoos GMBH - Site 1
Key facts
| Recall number (Z-number) | Z-1351-2018 |
|---|---|
| Recall event | 79533 |
| Product | Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments. |
| Product code | EBW |
| Recalling firm | W & H DentalWerk Burmoos GMBH - Site 1 |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 7, 2019 |
| 510(k) numbers | K060287 |
| FEI number | 3003755849 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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