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
This recall has been terminated (originally issued December 18, 2003).
- Company
- Q-Med Corporation
- Recall Initiated
- October 30, 2003
- Posted
- December 18, 2003
- Terminated
- July 11, 2012
- Recall Number
- Z-0246-04
- Quantity
- 1057 boxes of six devices each
- Firm Location
- Ft Lauderdale, FL
- Official Source
- View on FDA website ↗
Reason for Recall
This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
Distribution
Product was distributed to three wholesalers in Virginia and one in Illinois.
Lot / Code Info
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)
Root Cause
Other
Action Taken
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. '