FDA Medical Device Recalls (openFDA)
Owens & Minor Distribution, Inc.: 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***
- Recall number
- Z-0251-04
- 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***
- Status
- Terminated
- Initiated
- 2003-11-03
- Posted
- 2003-12-18
- Terminated
- 2011-08-04
- Reason
- Counterfeit product is an unapproved medical device with associated potential health hazard.
- 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
- CANNOT BE DETERMINED
- Distribution
- Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.
- Lot, serial or model codes
- Lots RBE609 EXP 1/07, RJJ130 EXP7/07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- not on file
- Firm city
- Glen Allen
- Firm state
- VA
- 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