J&J recalls Hemostatic Bone Putty – Class I recall

I have been writing about medical device recalls before  in few of my posts, mainly focusing on hip implant recalls. This posts is dedicated to share information about a medical implant that has been recently recalled. The purpose of this post is to bring attention to this recall and share official information released by the FDA.

Synthes a subsidiary of Johnson & Johnson has issued a Class I recall of several batches of bone graft called Hemostatic Bone Putty. Class I recalls are the most serious ones, meaning that these devices poses serious risks to patients. Reports indicate serious “fire hazards” with this medical device. Yes, you read it correctly. According to FDA information there is a high risk for ignition with contact of “electrosurgical cautery“.

Doctors and patients who experienced problems with the device in question are urged to report problems to the FDA.

Source: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm316472.htm