Synthes Recalls Bone Putty Over Possible Fire Hazard
A Class I recall of bone putty manufactured by Synthes was issued by the Food and Drug Administration (FDA) because the material may catch fire during surgery if it comes into contact with electrosurgical cautery systems.
A Class I recall is the most serious warning issued by federal regulators and is used if there is a risk of death or serious injury from a drug or other medical product.
The Hemostatic Bone Putty is used as a physical barrier to stop bleeding along the edges of a bone damaged due to trauma or cut during a surgical procedure, according to the recall notice.
In July 2012, a medical device recall letter was issued by Synthes requesting medical centers to examine their inventory for lots of bone putty manufactured from July 6, 2011, to Dec. 14, 2011.
The recalled product was distributed from December 22, 2011, to June 25, 2012. Any medical facilities that were in possession of the recalled bone putty should contact Synthes and return the product.
If you or someone you know has been harmed by an unsafe product, contact Sokolove Law for free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.