Johnson and Johnson Synthes Division Recalls Bone Putty As Product Could Catch on Fire During Surgery
Posted Aug 23 2012 7:57pm
Well J and J didn’t get a break with recalls and this is their new division that was purchased last year, Synthes. Occasionally there are fires in surgery but we don’t need a product that could contribute and thus the recall and this is a class one so all need to stop using the product immediately.
If you go back in history a few years with Synthes they had their subsidiary company Norian where four executives were charged with unlawful clinical trials and this too was a cement issue to where it reacted with blood to cause clots. I have no idea if this is the same product or not. BD
The Food and Drug Administration said Johnson & Johnson (JNJ) unit Synthes last month initiated a recall on certain lots of bone putty, saying the medical product could catch fire during surgery.
The FDA gave the recall a Class I designation, its most serious type of recall.
The regulator said Synthes in early July issued a medical device recall letter, asking medical facilities to examine their inventories and immediately stop using specific lots of the putty. The product, called a hemostatic bone putty, is used to stop bone bleeding by creating a physical barrier along the edges of bones that have been damaged by trauma or cut during surgery.