Reported Feb 9, 2022 · Ongoing
The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the…
FEMSelect Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: FEMSelect Ltd · HaMa'ayan 2 · Modi'in, N/A · N/A
Is this the product you have?
- 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 UseThe EnPlace system is intended for attaching sutures to ligaments of the pelvic floor
- Lot codes and dates
- UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD
- Lot Numbers21072510 and 21072512
- Amount recalled
- 141 units
Where it was sold
- Nationwide
- GA
Why it was recalled
Certain lots may not have been packaged wth the Channel Tube Limiter.
This product could cause temporary or reversible health problems — stop using it.
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