Z-0251-04

PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed...

Name: Z-0251-04 PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed...
Creator: Owens & Minor Distribution, Inc.
Published: 2003-11-03
License: https://open.fda.gov/license/

Owens & Minor Distribution, Inc. / initiated 2003-11-03 / Terminated

FDA source

Owens & Minor Distribution, Inc. began a recall of PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton... on 2003-11-03. The reason FDA records is "Counterfeit product is an unapproved medical device with associated potential health hazard". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0251-04
Status: Terminated
Initiated: 2003-11-03
Posted: 2003-12-18
Terminated: 2011-08-04
Recalling firm: Owens & Minor Distribution, Inc.
Product: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package, 6 packages per papercard carton. Cartons labeled in part ***ETHICON, INC., a Johnson & Johnson company SOMERVILLE, NEW JERSEY 08876-0151 ***STERILE: Sterility of contents guaranteed unless package has been opened or damaged***
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Counterfeit product is an unapproved medical device with associated potential health hazard.
FDA root cause: Other
Action: The distributor notified the firm's chain of warehouses by e-mail on 10/31/03 to identify, segregate and quarantine potential counterfeit product. The distributor then notified consignees by letter on 11/3/03. The letter advised that customers may have received 2 lots of counterfeit product and described the features for identity, which were provided by the manufacturer (www.ethicon.com) of the authentic product. The notification further instructed that appropriate healthcare professionals should be advised of the recall. Consignees were instructed to quarantine the specified lots for return.
Quantity in commerce: CANNOT BE DETERMINED
Distribution: Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.
Product codes and lots: Lots RBE609 EXP 1/07, RJJ130 EXP7/07

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)