Z-0246-04

Product is a surgical device packaged in a box which is labeled as Sterile with the following identification...

Name: Z-0246-04 Product is a surgical device packaged in a box which is labeled as Sterile with the following identification...
Creator: Q-Med Corporation
Published: 2003-10-30
License: https://open.fda.gov/license/

Q-Med Corporation / initiated 2003-10-30 / Terminated

FDA source

Q-Med Corporation began a recall of Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable... on 2003-10-30. The reason FDA records is "This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0246-04
Status: Terminated
Initiated: 2003-10-30
Posted: 2003-12-18
Terminated: 2012-07-11
Recalling firm: Q-Med Corporation
Product: Product is a surgical device packaged in a box which is labeled as Sterile with the following identification: ''PMII PROLENE Mesh Polypropylene Nonabsorbable Synthetic surgical Mesh ETHICON'' Additional infomation including comparisons between authentic Ethicon product and counterfeit are available at the following website: www.ethicon.com
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
FDA root cause: Other
Action: The firm e-mailed a Recall Notification Letter to the three wholesalers on 10/30/03 and also had telephone conversations with each of them concerning the recall. Their letter advises the accounts to subrecall down to the healthcare professional user level and also to quarantine suspect product. They also state: 'You should return any prolene mesh product to us if you are unsure whether the product you bought from us is authentic or counterfeit. '
Quantity in commerce: 1057 boxes of six devices each
Distribution: Product was distributed to three wholesalers in Virginia and one in Illinois.
Product codes and lots: The firm found in their inventory codes listed in the Ethicon notice of lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 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)