Synthes Hemostatic Bone Putty is the subject of a Class I recall because there is the potential for it to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
Hemostatic Bone Putty stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. 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.
Class I 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.
See the recall