Davol, Inc., maker of the recalled Composix® Kugel® hernia repair patch, has now voluntarily recalled its XenMatrix hernia and abdominal surgical graft.
In a filing with the U.S. Security and Exchange Commission, the company, a subsidiary of C.R. Bard, said it recalled the patch because of "a failure to meet the FDA's standards for endotoxins." Endotoxins, bacteria that can be toxic to the human body, may cause illnesses such as bacterial meningitis and meningococcal disease.
According to an article in The Wall Street Journal, Davol claims there have been no consumer complaints regarding the product.
There has also been no official announcement from the FDA about the recall of the XenMatrix patch. The patch was acquired by Davol in 2009 from Brennan Medical and is a collagen matrix patch used to treat hernias.
Davol initially recalled its Composix Kugel Mesh patch in December 2005 after it was discovered that the memory recoil ring, which opens the patch, can break under the stress of placement in the intra-abdominal space. Between December 2005 and March 2006, and again in January 2007, the recall notice was updated to include additional product codes and lot numbers. The company faces thousands of lawsuits over the Composix Kugel Mesh hernia repair patch in both federal and state court.
Read the FDA medical device saftey alert here.
Learn more about how Motley Rice medical attorneys are fighting on behalf of patients who may have suffered injuries or complications related to hernia repair patches.