Don’t Yell Fire in the O.R.: J&J Issues Another Recall – Bone Putty Could Ignite
Once again, a Johnson & Johnson (JNJ) unit has issued a product recall. The latest involves various lots of hemostatic bone putty, which is used to stop bone bleeding during surgery. Why a recall? The FDA says the potential exists for the putty to ignite if it were to come into contact with electrosurgical cautery systems under certain conditions. Imagine a surgeon’s surprise when a patient suddenly catches fire.
The recall was classified as Class I, which is the most serious type of recall where the chance of serious outcomes or even death exists. According to the agency, Synthes actually issued a recall letter on July 5 that requested medical facilities to examine their inventories and immediately stop using the identified lot numbers for putty manufactured between July 6, 2011 and December 14, 2011. The putty had been distributed between last December and June 25 (read more Pharma news here).
Of course, a company as large and diverse as J&J is going to issue a recall now and then. But the health care giant has been under a microscope for more than two years in which a wide array of items have been recalled – from tens of millions of over-the-counter meds, including Tylenol and Motrin; contact lenses; epilepsy drugs and hip replacement devices, among other items. There have also been embarrassing shortages of Tampons and shampoos. In June, J&J halted marketing of four vaginal mesh implants that have been the subject of lawsuits filed by approximately 1,000 women who claim the products have caused serious internal injuries. Background on J&J's troubles in Pharma news and more <Pharma news./p>
To read the remainder of this article, go to Pharmalot.
Filed under: Company Analysis