Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The EnPlace is a single use trans-vaginal pelvic floor repair Recalled by FEMSelect Ltd Due to Certain lots may not have been packaged wth...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact FEMSelect Ltd directly.
Affected Products
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
Why Was This Recalled?
Certain lots may not have been packaged wth the Channel Tube Limiter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About FEMSelect Ltd
FEMSelect Ltd has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report