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