FEMSelect Ltd recalls The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the l…

Recall date

December 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0556-2022

FDA classification

Class II

Brand / firm

FEMSelect Ltd

Sold / distributed

US Nationwide distribution in the state of Georgia.

Why it was recalled

Certain lots may not have been packaged wth the Channel Tube Limiter.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.