A product used in hernia and abdominal wall repair is being recalled by the manufacturer because it may contain toxins that can be deadly to humans. The Class 1 recall involves certain lots of XenMatrix Surgical Grafts. Class 1 recalls are the most serious type of recall issued by the Food and Drug Administration (FDA) and involve situations where there is a strong probability where the product may cause serious injury or death.
The surgical grafts are routinely tested to ensure that endotoxin levels are within FDA requirements, however testing found that certain lots of the XenMatrix Surgical Grafts had elevated endotoxin levels. Endotoxins (pyrogens) are substances found in certain bacteria that, at elevated levels, can cause serious illnesses which can be fatal. In pharmaceutical production, it is necessary to remove all traces of endotoxin from drug product containers as even small amounts of endotoxin will cause illness in humans.
XenMatrix sent letters to its customers notifying them of the recall and instructing them to return the recalled units. Health care providers and consumers should report any side effects with the surgical grafts or any other medical product to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.