Device 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.
Z-0556-2022
Product summary
- Firm
- FEMSelect Ltd
- Event
- Event 89309
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 141 units
- Official record key
device-enforcement:Z-0556-2022
Official wording
Reason: Certain lots may not have been packaged wth the Channel Tube Limiter.
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.
Derived failure modes
-
Unknown
Certain lots may not have been packaged wth the Channel Tube Limiter.