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.
Recall
- Recall Number
- Z-0556-2022
- Event Number
- 89309
- Firm
- FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel
- FEI Number
- 3010892271
- Product Code
- PBQ
- Status
- Open, Classified
- Root Cause
- Process design
- Initiated
- December 13, 2021
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.
Certain lots may not have been packaged wth the Channel Tube Limiter.
On Monday, December 13, 2021, FEMSelect alerted the US distributor both by phone and with a letter sent by email. The formal Recall Notice was sent on December 14, 2021. The recalling firm is requesting the return of the devices.
US Nationwide distribution in the state of Georgia.
141 units