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Terminated

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

FDA Recall Z-0246-04 · Posted 2003-12-18

Recalling FirmQ-Med Corporation
Recall StatusTerminated
Product CodeFTL
Date Initiated2003-10-30
Date Terminated2012-07-11
Product Quantity1057 boxes of six devices each

Reason for Recall

This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.

Firm 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. '

Root Cause

Other

Distribution Pattern

Product was distributed to three wholesalers in Virginia and one in Illinois.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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