FDA Device recall Z-0556-2022
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vagi…
- FDA Device
- Class II
- ongoing
- Published 2022-02-09
On 2022-02-09 the FDA classified a Class II recall of The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vagi… by Femselect, citing certain lots may not have been packaged wth the Channel Tube Limiter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0556-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-12-13 |
| Published | 2022-02-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Femselect |
| Distribution | US |
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.
Reason
Certain lots may not have been packaged wth the Channel Tube Limiter.
Identifiers
| code_info | UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0556-2022%22
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