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Thursday, March 10, 2011

Another Hernia Patch Recall by FDA

FdaImage via WikipediaThe US Food and Drug Administration (FDA) issued another hernia and abdominal patch recall. The FDA on March 4, 2011 issued a Class 1 Recall Notice for Davol's XenMatric Surgical Graft.

The FDA indicated that the recall was issued because “Testing cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. Several lots have been found to have elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illness which can be fatal.”

This product was manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010. For more information, please see the FDA’s safety alert.

Litigation is pending against Davol, Inc. is pending in both federal and state court on behalf of patients who suffered serious injuries or complications related to the company’s Composix® Kugel® Mesh hernia repair patch.