FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel
Lot Codes / Batch Numbers
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
Products Sold
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel is recalling The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tis due to Certain lots may not have been packaged wth the Channel Tube Limiter.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Certain lots may not have been packaged wth the Channel Tube Limiter.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026