Z-0556-2022Class II

The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue...

Name: Z-0556-2022 The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue...
Creator: FEMSelect Ltd
Published: 2021-12-13
License: https://open.fda.gov/license/

FEMSelect, Inc. / initiated 2021-12-13 / Open, Classified / root cause: manufacturing process

FDA source

FEMSelect Ltd began a recall of 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... on 2021-12-13. FDA classified it as Class II and gives the reason as "Certain lots may not have been packaged wth the Channel Tube Limiter". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0556-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-13
Posted: 2022-02-02
Recalling firm: FEMSelect, Inc.
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.
Product code: PBQ Fixation, Non-Absorbable Or Absorbable, For Pelvic Use
Reason for recall: Certain lots may not have been packaged wth the Channel Tube Limiter.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 141 units
Distribution: US Nationwide distribution in the state of Georgia.
Product codes and lots: UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0556-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0556-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-02-02

Product code PBQ

K160569Class IINeuGuidePop Medical Solutions / cleared 2016-07-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)