Z-0249-04

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

Name: Z-0249-04 PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch...
Creator: McKesson General Medical Corporation
Published: 2003-10-31
License: https://open.fda.gov/license/

McKesson General Medical Corporation / initiated 2003-10-31 / Terminated

FDA source

McKesson General Medical Corporation 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 2003-10-31. 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-0249-04
Status: Terminated
Initiated: 2003-10-31
Posted: 2004-07-20
Terminated: 2011-08-04
Recalling firm: McKesson General Medical Corporation
Product: PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
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 all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03.
Quantity in commerce: 180 cartons
Distribution: Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
Product codes and lots: All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.

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)