FDAnews Device Daily Bulletin

FDA ISSUES CLASS 1 RECALL ON BARD KUGEL MESH PATCH

April 4, 2006
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The FDA has recalled the Composix Kugel Mesh Patch, used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that forms after surgery. The recall notice was updated from a previous listing to include additional product codes and lot numbers not previously listed.

The patch is placed behind the hernia defect through a small incision and is then held open by a "memory recoil ring" that allows the patch to be folded for insertion and later spring open and lay flat once it is in place.

The recalling manufacturer, Davol, said "memory recoil ring" can break under the stress of placement of the large sized products in the intra-abdominal space. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). Access the link at www.fda.gov/cdrh/recalls/recall-122205.html (http://www.fda.gov/cdrh/recalls/recall-122205.html) for the codes.