Z-0556-2022 Class II Ongoing
FDA device recall Z-0556-2022 was initiated by FEMSelect Ltd on December 13, 2021 and is designated Class II. Reason for recall: Certain lots may not have been packaged wth the Channel Tube Limiter. The recall status is ongoing. Affected quantity: 141 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 9, 2022
- Initiation Date
- December 13, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 141 units
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.
Distribution Pattern
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.