Z-0243-04

Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile...

Name: Z-0243-04 Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile...
Creator: Cardinal Health
Published: 2003-11-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2003-11-03 / Terminated / root cause: labeling and UDI

FDA source

Cardinal Health began a recall of Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ... on 2003-11-03. The reason FDA records is "Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0243-04
Status: Terminated
Initiated: 2003-11-03
Posted: 2003-12-18
Terminated: 2008-11-18
Recalling firm: Medtronic, Inc.
Product: Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Cardinal Health notified all of their hospital accounts who ordered catalog PMII by letter dated 11/3/03, alerting them to the two lots identifed as counterfeit and requesting the accounts to place all lots on hold in quarantine until further instructions are received. The accounts were requested to call Cardinal Health Customer Service at 800-964-5227 to arrange for product replacement. Cardinal Health customers were sent a follow-up letter dated 11/11/03 with product disposition information, instructing them to return all products bearing lot numbers RBE609 and RJJ130 and all boxes of Prolene with orange dots on the end of the box to Cardinal Health, and to closely examine any remaining boxes to the labeling posted on Ethicon''s website www.Ethicon.com.
Quantity in commerce: 365 boxes
Distribution: Nationwide
Product codes and lots: Catalog number PMII, lot numbers RBE609, expiration date 1/07, and RJJ130, expiration date 7/07 Note: any box with an orange dot on the end of the box is suspected counterfeit product, regardless of lot number.

Product code FTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)