Synthes Bone Putty Recalled for Fire Risk

DePuy Synthes has issued a Class I recall of Synthes Hemostatic Bone Putty due to a risk the putty may ignite if it comes into contact with electrosurgical cautery systems under certain conditions during orthopedic surgery.

 Synthes issued a recall letter to medical facilities on July 5, asking them not to use the putty, according to the FDA’s MedWatch system.

The recall followed one report of putty catching fire. No patient injuries were reported, Synthes spokeswoman Lorie Gawreluk said.

Recalls are expensive and often lead to more serious financial consequences — not only from the FDA but also from courts and unhappy shareholders. Luckily, FDAnews is offering the Medical Device Quality & Compliance Institute 2012: Quality Systems and Design Control Training.

These two courses, presented by EduQuest in cooperation with FDAnews, are offered separately or as an integrated three-and-a-half-day learning package. Learn how to develop a by-the-book quality management program and leave the guessing to your competitors.