Recall Z-0251-04 ยท FTL Mesh, Surgical, Polymeric
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***
| Date | Dec 18, 2003 (initiated Nov 3, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.