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.
FDA Recall Z-0556-2022 · Posted None
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Recalling FirmFEMSelect Ltd
Recall StatusOpen, Classified
Product CodePBQ
Date Initiated2021-12-13
Product Quantity141 units
Reason for Recall
Certain lots may not have been packaged wth the Channel Tube Limiter.
Firm Action
On Monday, December 13, 2021, FEMSelect alerted the US distributor both by phone and with a letter sent by email. The formal Recall Notice was sent on December 14, 2021. The recalling firm is requesting the return of the devices.
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the state of Georgia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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