Recall Z-0556-2022 ยท PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
FEMSelect Ltd
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 guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlac
| Date | Dec 13, 2021 |
| Status | Open, Classified |
| Reason | Certain lots may not have been packaged wth the Channel Tube Limiter. |
| Root cause | Process design |
| Action | On Monday, December 13, 2021, FEMSelect alerted the US distributor both by phone and with a letter sent by email. The formal Recall Notice was sent on December 14, 2021. The recalling firm is requesting the return of the devices. |
| Quantity | 141 units |
| Distribution | US Nationwide distribution in the state of Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160569 | NeuGuide Pop Medical Solutions, Jul 6, 2016 |