Z-0795-2007

Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland

Name: Z-0795-2007 Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
Creator: Ethicon, Inc.
Published: 2007-04-20
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2007-04-20 / Terminated

FDA source

Ethicon, Inc. began a recall of Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland on 2007-04-20. The reason FDA records is "The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0795-2007
Status: Terminated
Initiated: 2007-04-20
Posted: 2007-05-10
Terminated: 2008-03-04
Recalling firm: Ethicon, Inc
Product: Gynecare PROLIFT Total Pelvic Repair System PFRT01 Ethicon Deutschland
Product code: FTM Mesh, Surgical
Reason for recall: The pre-printed outer box incorrectly identifies the product as GYNECARE PROLIFT Total Pelvic Floor System (Product Code PFRT01). The contents of the box actually contain GYNECARE PROLIFT Anterior Pelvic Floor System (Product Code PFRA01)
FDA root cause: Other
Action: Recall notifications were sent by 2nd day air UPS delivery on April 20, 2007 to all hospitals Director of Surgery, OR Managers and Materials Managers.
Quantity in commerce: 160 units to US
Distribution: Nationwide
Product codes and lots: Product Code PFRT01 Lot Number 2990052 2007-12

Product code FTM

K013718Class IIGynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor RepairGynecare, A Div. of Ethicon, Inc. / cleared 2002-01-08

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)