Synthes Hemostatic Bone Putty: Class I Recall - Potential for Putty to Ignite
MedSun: Newsletter #76, September 2012
FDA MedWatch Safety Alert
There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. On July 5, 2012, Synthes issued a Medical Device Recall letter requesting medical facilities to examine their inventory and immediately stop using the identified part and lot numbers of the Hemostatic Bone Putty.
Additional Information:
FDA MedWatch Safety Alert. Synthes Hemostatic Bone Putty: Class I Recall - Potential for Putty to Ignite. August 21, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316472.htm