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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm November 03, 2003
Date Posted December 18, 2003
Recall Status1 Terminated 3 on August 04, 2011
Recall Number Z-0251-04
Recall Event ID 27656
Product Classification Mesh, Surgical, Polymeric - Product Code FTL
Product 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***
Code Information Lots RBE609 EXP 1/07, RJJ130 EXP7/07
Recalling Firm/
Manufacturer		 Owens & Minor Distribution, Inc.
4800 Cox Road
Glen Allen VA 23060
For Additional Information Contact Grant Issette
804-965-5891
Manufacturer Reason
for Recall		 Counterfeit product is an unapproved medical device with associated potential health hazard.
FDA Determined
Cause 2		 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 in Commerce CANNOT BE DETERMINED
Distribution Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.
Total Product Life Cycle TPLC 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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