Recall Z-0246-04 ยท FTL Mesh, Surgical, Polymeric
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
| Date | Dec 18, 2003 (initiated Oct 30, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.