Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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

U.S. FDA — Device Enforcement · Israel · 2021-12-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0556-2022
Date of alert: 2021-12-13
Country / jurisdiction: Israel
Risk level: Class II
Risk type: recall
Brand: FEMSelect Ltd
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 07290017

Reported risk: Certain lots may not have been packaged wth the Channel Tube Limiter.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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