Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels
MedSun: Newsletter #59, April 2011

FDA MedWatch Safety Alert

FDA notified healthcare professionals that several lots of XenMatrix Surgical Graft 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. Customers should contact Davol Customer Service for instructions on how to return the products.

Additional Information:

FDA MedWatch Safety Alert. Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels. March 4, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245720.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun