AUDUBON, Pa. (February 29, 2012) – Globus Medical, Inc., today announced that it and David Paul, Chairman and CEO of Globus Medical, have reached a settlement with the U.S. Food and Drug Administration to resolve an administrative complaint alleging Food, Drug and Cosmetic Act violations regarding Globus’ former product, NuBone™. There were no patient safety issues reported regarding NuBone™. Significantly, the Amended Complaint does not allege any intentional wrongdoing by Globus Medical or Mr. Paul.
Globus had considered NuBone™ to be minimally manipulated tissue exempt from premarket notification, but in March 2008 the FDA’s Tissue Reference Group determined that NuBone™ required 510(k) clearance. Globus and FDA maintained an ongoing dialogue regarding NuBone’s regulatory status including two 510(k) submissions with substantial animal data. During that time Globus regularly communicated with FDA regarding NuBone™ and throughout NuBone’s lifecycle believed that it was acting in a manner that was acceptable to FDA. Despite its history of safe use, Globus decided to discontinue NuBone™ in 2010.
“Globus strives to conduct our business in a manner that is consistent with the highest legal standards in our industry. In this particular situation, there was an unfortunate miscommunication between Globus and FDA such that we believed we were acting in a manner that was acceptable to FDA. We accept full responsibility and are pleased to have resolved this matter without further legal action, and look forward to a continuation of our long standing relationship with FDA, based on cooperation and mutual respect” commented Mr. Paul.