FEMSelect Ltd: Medical Device Recall in 2022 - (Recall #: Z-0556-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: December 13, 2021

Date Posted: February 9, 2022

Recall Number: Z-0556-2022

Event ID: 89309

Reason for Recall:

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

Status: Ongoing

Product Quantity: 141 units

Code Information:

UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.

Distribution Pattern:

US Nationwide distribution in the state of Georgia.

Voluntary or Mandated:

Voluntary: Firm initiated