Device recall
Z-0556-2022: The EnPlace is a single use trans-vaginal pelvic floor repair system which…
FDA device recall · Class II · FEMSelect Ltd
Key facts
| Recall number (Z-number) | Z-0556-2022 |
|---|---|
| Recall event | 89309 |
| Product | The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a… |
| Product code | PBQ |
| Recalling firm | FEMSelect Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160569 |
| FEI number | 3010892271 |
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