FEMSelect Ltd recalls The EnPlace is a single use trans-vaginal pelvic floor repai
Recalled 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.
Hazard / Issue
Certain lots may not have been packaged wth the Channel Tube Limiter.
Issued by
FDA
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