Davol Inc.’s recall of its XenMatrix Surgical Graft, which we reported in January, has been deemed a Class I recall by the U.S. Food & Drug Administration (FDA), it’s most serious recall classification. XenMatrix, made from pig tissue, is used in hernia and abdominal wall repair.
According to the recall notice, Davol, a unit of C.R. Bard, cannot confirm that all units of XenMatrix Surgical Graft are within FDA requirements for endotoxin levels. In fact, several lots have been found to have elevated endotoxin levels. Endotoxins are substances found in certain bacteria that, at elevated levels, can cause serious and potentially fatal illness.
As we reported in January, the XenMatrix Surgical Graft recall was initially announced in a filing with the U.S. Security and Exchange Commission. At that time, there had been no official FDA announcement.
This recall involves XenMatrix Surgical Graft products that carry lot numbers that start with the following four letters: HUTF, HUTI, HUTJ, HUTK, HUTL, HUUA, HUUB, HUUC, HUUD, HUUE, HUUF, HUUG, HUUH, and HUUJ. The recalled XenMatrix grafts were manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010.
On January 6, 2011, Davol sent its customers a recall letter requesting that the recalled XenMatrix units be returned.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
This is not the first time a device marketed by C.R. Bard and Davol has been the subject of safety concerns. Between December 2005 and March 2006, specific lot numbers of Davol’s defective Composix Kugel Mesh hernia repair patches were recalled after it was found that the memory recoil ring, which opened the patch, could potentially break under the stress of placement in the intra-abdominal space and lead to chronic intestinal problems such as bowel perforations and chronic intestinal fistulae. Thousands of lawsuits involving the Kugel Mesh patch have since been filed against Davol and C.R. Bard.
Recently, lawsuits have also been filed alleging Bard was negligent in designing its Avaulta vaginal mesh, and failed to warn patients of possible complications with the product. Lawsuits involving the Bard Avaulta mesh have been consolidated in a multidistrict litigation in the U.S. District Court for the Southern District of West Virginia. The Bard Avaulta lawsuits will be presided over by U.S. District Judge Joseph Goodwin.