Davol XenMatrix Surgical Graft: Class I Recall – Elevated Endotoxin Levels

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Davol XenMatrix Surgical Graft: Class I Recall – Elevated Endotoxin Levels

AUDIENCE: Risk Manager, Surgery

ISSUE: 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. This product was manufactured from June 1, 2010 through October 31, 2010 and distributed from July 1, 1010 through October 31, 2010. See the Recall Notice for a listing of specific lots affected by this recall.

BACKGROUND: This product is used in hernia and abdominal wall repair.

RECOMMENDATION: Customers should contact Davol Customer Service for instructions on how to return the products.

 

Read the MedWatch safety alert, including a link to the Class I Recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245720.htm

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