FDA Issues Recall of Davol XenMatrix Surgical Graft
Posted By The Carlson Law Firm || 26-Aug-2011
Since the Davol, Inc. Compsix® Kugel® Mesh Hernia Patchwas approved by the FDA in 1996, it has plagued the medical community with numerous voluntary recalls in 2005, 2006 and again in 2007, resulting in product liability cases. But Davol has continued to experience such recalls with the newly released product XenMatrix® Surgical Graft.
Manufactured during June 2010 through October 2010, the XenMatrix Surgical Graft was recalled by the Food and Drug Administration (FDA), in March 2011. Like the previous introduction of the Kugel Mesh hernia patch, the XenMatrix Surgical Graft is a medical device that is used to repair the abdominal wall and hernias.
“Testing cannot confirm that all units of the XenMatrix Surgical Graft are within FDA requirements,” the administration said. “Several lots have been found to have elevated Endotoxin levels.”
Pyrogens, the endotoxin levels the FDA warns consumers about, are located in bacteria, posing serious risks when present in high amounts. In addition to the health hazards associated with high endotoxin levels, the graft could possibly present consumers with fatal results.
Classified by the FDA as a Class I recall, the XenMatrix Surgical Graft is listed in one of the most serious classifications due to high chances of causing serious injury and even death. Although the FDA issued a recall in March 2011, Davol Inc. also sent consumers a recall issue earlier this year, prior to FDA consumer notification.