The EnPlace is a single use trans-vaginal pelvic floor repair system which ...



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 EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
Components:
Recall Date:    Dec 13, 2021
Mfg:
FEMSelect Ltd
Mfg Country:
Israel
Recall ID:    89309
Product ID:    191247
Enforcement Date:    Feb 9, 2022
Last Published:    Feb 2, 2022

__________

Emert Number:    Z-0556-2022
Emert Status:    Notified