Synthes Hemostatic Bone Putty: Class I Recall — Potential for Putty to Ignite

The US Food and Drug Administration has issued a recall notice about a putty, classed as a medical device, which has the risk of exploding when used in 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. The risk is that “there is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.” For further details see FDA Medwatch