Z-1019-04

Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1

Name: Z-1019-04 Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
Creator: American Medical Systems
Published: 2003-07-28
License: https://open.fda.gov/license/

American Medical Systems, Inc. / initiated 2003-07-28 / Terminated / root cause: packaging

FDA source

American Medical Systems began a recall of Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 on 2003-07-28. The reason FDA records is "Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1019-04
Status: Terminated
Initiated: 2003-07-28
Posted: 2004-07-20
Terminated: 2004-06-22
Recalling firm: American Medical Systems, Inc.
Product: Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.
Root cause tag: packaging
FDA root cause: Other
Action: The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement.
Quantity in commerce: 62 units
Distribution: The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium.
Product codes and lots: Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international)

Product code FTL

K023516Class IIMonarc Sling SystemAmerican Medical Systems, Inc. / cleared 2002-11-19

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)