PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3''x6'', each mesh in a sealed pouch package,

FDA device recall Z-0251-04 · posted 2003-12-18 · Terminated

Recall details

Recalling firm

Owens & Minor Distribution, Inc.

Reason for recall

Counterfeit product is an unapproved medical device with associated potential health hazard.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FTL

Quantity affected

CANNOT BE DETERMINED

Distribution

Counterfeit and authentic product was distributed to warehouses and 205 medical facilities nationwide.

Date initiated

2003-11-03

Date posted

2003-12-18

Date terminated

2011-08-04

Location

Glen Allen, VA