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U.S. Department of Health and Human Services

Class 2 Device Recall PROLENE

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 Class 2 Device Recall PROLENEsee related information
Date Initiated by FirmOctober 30, 2003
Date PostedDecember 18, 2003
Recall Status1 Terminated 3 on July 11, 2012
Recall NumberZ-0246-04
Recall Event ID 27613
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
ProductProduct 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
Code Information 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)
Recalling Firm/
Manufacturer		 Q-Med Corporation
3801 SW 30th Ave
Ft Lauderdale FL 33312-6819
For Additional Information ContactJ. Carlos Rodriguez
954-316-1212
Manufacturer Reason
for Recall		This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce1057 boxes of six devices each
DistributionProduct was distributed to three wholesalers in Virginia and one in Illinois.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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