medical Class II Updated 2022-02-09

FEMSelect Ltd recalls The EnPlace is a single use trans-vaginal pelvic floor repai

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
View official government recall

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