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U.S. Department of Health and Human Services

Class 2 Device Recall EnPlace

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 Class 2 Device Recall EnPlacesee related information
Date Initiated by FirmDecember 13, 2021
Create DateFebruary 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0556-2022
Recall Event ID 89309
510(K)NumberK160569 
Product Classification Fixation, non-absorbable or absorbable, for pelvic use - Product Code PBQ
ProductThe 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.
Code Information UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
FEI Number 3010892271
Recalling Firm/
Manufacturer		 FEMSelect Ltd
HaMa'ayan 2
First Floor
Modi'in Israel
Manufacturer Reason
for Recall		Certain lots may not have been packaged wth the Channel Tube Limiter.
FDA Determined
Cause 2		Process design
ActionOn 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.
Quantity in Commerce141 units
DistributionUS Nationwide distribution in the state of Georgia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PBQ
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