Class II — FEMSelect Ltd
| Recalling firm | FEMSelect Ltd |
|---|---|
| Registered facility | FEMSelect Ltd (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Certain lots may not have been packaged wth the Channel Tube Limiter. |
| 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. |
| Quantity | 141 units |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Initiated | 2021-12-13 |
| Classified | 2022-02-02 |
| Recall number | Z-0556-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — FEMSelect Ltd (Z-0556-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89309/
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