On March 4, 2011, the Food and Drug Administration (FDA) issued a Class I recall of Davol, Inc.'s XenMatrix Surgical Graft, a device used in hernia and abdominal wall repair.
According to the FDA, 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.
Motley Rice is currently litigating cases against Davol, Inc. in both federal and state court on behalf of clients who suffered serious injuries or complications related to the company's Composix® Kugel® Mesh hernia repair patch.
Learn more about how Motley Rice device lawyers are fighting on behalf of patients who may have suffered injuries or complications related to defective medical devices.