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FEMSelect Ltd recalls The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the li
Recalled February 9, 2022 · FDA recall Z-0556-2022 · FEMSelect
Hazard
Certain lots may not have been packaged wth the Channel Tube Limiter. · FDA Class II
Units
141 units
Sold at
US Nationwide distribution in the state of Georgia.
Description
Certain lots may not have been packaged wth the Channel Tube Limiter.
Product
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.
Manufacturer(s)
FEMSelect Ltd
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →