FDADecember 13, 2021device

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 a...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

femselect

UPCs

07290017082011

Recall history

No related federal recalls on record for this brand yet.

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