Newly acquired Synthes Inc. recalled certain lots of its Hemostatic Bone Putty over concerns that the product may catch on fire in certain conditions.
The product, which is used to stop bone bleeding by establishing a physical barrier along the edges of bones, should be returned to Synthes, according to the FDA notice.
The federal watchdog agency categorized the measure a Class 1, a label reserved for recalls which 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."
"There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
There was only 1 listing in the FDA’s MAUDE adverse event reporting database relating to Synthes’ Hemostatic Bone Putty, and it was not related to the incident inciting the recall.