The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a ...
FDA Recall #Z-0556-2022 — Class II — December 13, 2021
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.
Reason for Recall
Certain lots may not have been packaged wth the Channel Tube Limiter.
Recalling Firm
FEMSelect Ltd — Modi'in, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
141 units
Distribution
US Nationwide distribution in the state of Georgia.
Code Information
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.