FDA Enforcement
Class II
Ongoing
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: Z-0556-2022
·
Reported February 9, 2022
Enforcement
- Recall Number
- Z-0556-2022
- Event ID
- 89309
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- FEMSelect Ltd
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- February 9, 2022
- Initiation Date
- December 13, 2021
- Classification Date
- February 2, 2022
- Address
- HaMa'ayan 2, First Floor, Modi'in, N/A, N/A, Israel
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
Certain lots may not have been packaged wth the Channel Tube Limiter.
Code Info
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
Distribution
US Nationwide distribution in the state of Georgia.
Quantity
141 units