The EnPlace is a single use trans-vaginal pelvic floor repair system… — Class II medical device recall Z-0556-2022
Ongoing recall by FEMSelect Ltd, reported 2022-02-09, distributed nationwide. Certain lots may not have been packaged wth the Channel Tube Limiter.
| Recall number | Z-0556-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | FEMSelect Ltd, Modi'in, N/A, Israel |
| Recall initiated | 2021-12-13 |
| Classified | 2022-02-02 |
| Reported by FDA | 2022-02-09 |
| Distributed | Nationwide (US) |
| Quantity | 141 units |
| Lot numbers | 21072510, 21072512 |
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 for recall
Certain lots may not have been packaged wth the Channel Tube Limiter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0556-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.