Globus Medical is a spinal implant manufacturer privately held in Audubon, Pennsylvania. The FDA considers Globus Medical’s NuBone Osteoinductive a medical device that poses a lower level of risk to patients and therefore Globus Medical was only required to show that the NuBone Osteoinductive was substantially equivalent to similar medical devices that are already on the market. However, FDA investigators learned the company had marketed its NuBone Osteoinductive Bone Graft product without proper regulatory approval during a September 2010 inspection.
Globus Medical and its chief executive have reached a $1 million settlement with the U.S. Food and Drug Administration for selling unapproved devices. The settlement requires Globus Medical to pay a $550,000 penalty and David Paul, its CEO, to pay $450,000, FDA said in a statement.
“Spine implant maker fined for unapproved devices.”Reuters. 28 02 2012 <http://kdal610.com/news/articles/2012/feb/28/spine-implant-maker-fined-for-unapproved-devices/>.