FEMSelect Ltd Recall: The EnPlace is a single use trans-vaginal pelvic floor repair system
FEMSelect Ltd Recall: The EnPlace is a single use trans-vaginal pelvic floor repair system is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: FEMSelect Ltd; Product: The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligam
| Recalling firm | FEMSelect Ltd |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Recall initiated | 20211213 |
| Recall number | Z-0556-2022 |
| Category | device |
| State | N/A |
| Country | Israel |
$29/mo
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