Johnson & Johnson Recalls Bone Putty for Potential Fire Hazard

The Federal Drug Administration (FDA) has announced a Class I recall of Johnson & Johnson Synthes Hemostatic Bone Putty. The announcement states that there exists a potential for the putty to catch fire if it comes in contact with electro-surgical systems, such as cauterizing systems, during surgery.

The bone putty is used to stop bleeding along the edges of bones that have been damaged or cut due to trauma or surgical procedures. The putty acts as a physical barrier to stem the bleeding. However, in several instances the putty has ignited under certain surgical conditions.

A Class I recall is the most serious type of recall issued by the FDA. A Class I recall is issued when the FDA feels there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

On July 5, 2012, after recognizing the problem, Johnson & Johnson issued a letter to medical facilities requesting that they review their inventory for the affected product and lot numbers. The facilities were requested to stop use of the product immediately. The affected putty lots were manufactured between July 6, 2011 and December 14, 2011.

Continued Recall Troubles for Johnson & Johnson

Johnson & Johnson acquired Synthes in June 2012 for $21.3 billion. Synthes is a specialized medical device company that produces spine and bone repair products. The Synthes unit is based in West Chester, Pa. By merging Synthes and its beleaguered DePuy unit, Johnson & Johnson was hoping to boost its orthopedic division.

The Synthes unit has recently come under fire for several product recalls and is struggling to improve its image. Additionally, the largely publicized recall of the DePuy metal hip implant and its related lawsuits has hit the company hard. Johnson & Johnson has recently been subjected to over $3 billion in charges, mainly due to legal settlements and other products liability issues, mostly stemming from DePuy devices. This latest recall of its Hemostatic Bone Putty may open the door for additional product liability lawsuits. Johnson & Johnson is already reporting that its Medical Devices & Diagnostics division is experiencing declining sales figures.

Facilities who have located the affected product are asked to contact Synthes directly, in order to return it to the manufacturer. Even if no product is found, medical facilities should acknowledge receipt of the recall notification in order to ensure notification coverage in all areas.

The FDA will continue to monitor the recall as it progresses.