FDA Medical Device Recalls (openFDA)
Q-Med Corporation: 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
- Recall number
- Z-0246-04
- 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
- Status
- Terminated
- Initiated
- 2003-10-30
- Posted
- 2003-12-18
- Terminated
- 2012-07-11
- Reason
- This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
- 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
- 1057 boxes of six devices each
- Distribution
- Product was distributed to three wholesalers in Virginia and one in Illinois.
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 3003157840
- Firm city
- Ft Lauderdale
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28