Synthes Hemostatic Bone Putty Recall Issued Due to Surgical Fire Risk

A putty used to stop bones from bleeding may burst into flames, causing a surgical fire, federal health officials warn. 

The FDA announced a Class 1 medical device recall for Synthes Hemostatic Bone Putty this week, after the company sent a letter to its customers last month urging them to stop using certain lots.

Synthes’ a subsidiary of Johnson & Johnson, alerted users to the potential that the bone putty could be ignited by electrosurgical cautery systems under certain conditions.

The FDA’s decision to classify the Hemostatic Bone Putty recall as Class I indicates that the agency believes there is a reasonable probability that using the product will cause severe injury or death. It is unclear from the recall notices whether anyone has actually died or been injured due to a surgery fire from the bone putty.

Synthes Hemostatic Bone Putty is used to prevent blood loss from bones that have been damaged by trauma or cut during surgery.

The recall affects all lots of Hemostatic Bone Putty with the part numbers of 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. The putty was manufactured between July 6, 2011 and December 14, 2011, and distributed between December 22, 2011 and June 25, 2012.

There are about 550 to 650 surgery fires every year, according to data gathered by the Pennsylvania Patient Safety Reporting System in 2007.

Last year, the FDA launched a new initiative designed to prevent operating room fires by increasing awareness about the causes of surgical fires and practices that can reduce the risk of such events.

Approximately one or two surgical fire deaths occur every year, but many more patients suffer severe and disfiguring burns as a result of the fires that are often started by a combination of electrosurgical tools, oxygen, and flammable hospital drapes.

Synthes is asking medical facilities to check their inventory for the recalled bone putty and to call (800) 479-6329 for a Return Authorization Number if they find that they have the putty in stock.