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FDA Issues Class I Recall for Hernia Patches

Posted on March 23rd, 2011 No Comments

A Class I recall has been issued for several lots of hernia repair patches.

According to officials with the United States Food and Drug Administration, the hernia repair grafts may contain high levels of various endotoxins. Rhode Island-based medical products manufacturer Davol sent a letter to healthcare providers calling for the return of its XenMatrix Surgical Graft, the agency said. High levels of bacteria present in the graft may cause serious illness or fatalities.

The recall involves grafts made and distributed between July 1 and October 31, 2010.

The grafts are used in hernia and abdominal wall repair procedures. The company describes the grafts as “non-cross-linked, regenerative porcine collagen matrix.”

The FDA says it has not received reports of adverse events relating to the grafts in question.

To learn more about hernia patch failures, please contact the AlloDerm Lawsuit Attorneys of Williams Kherkher by calling 800-761-3187.


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