The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the li
Summary
The FDA issued a Class II for The EnPlace is a single use trans-vaginal pelvic floor repair system which enabl by FEMSelect Ltd. Reason: Certain lots may not have been packaged wth the Channel Tube Limiter..
Details
Source
Device Recall
External ID
Z-0556-2022
Action Date
2022-02-09
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
Quantity Affected: 141 units
Reason for Recall
Certain lots may not have been packaged wth the Channel Tube Limiter.
Distribution
US Nationwide distribution in the state of Georgia.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-13
Company
Modi'in, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (FEMSelect Ltd) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does FEMSelect Ltd have FDA actions?
This is the only FDA action we have on record for FEMSelect Ltd in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0556-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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