Orthopedics device maker Globus Medical and its CEO agree to pay a $1 million fine after an FDA inspection finds the company marketing bone graft products that the agency had denied for the U.S. market.
Orthopedics device maker Globus Medical will pay $1 million, including a find for its chief officer, to settle FDA charges that the company marketed bone graft products without getting the agency’s approval.
The fine includes $550,000 in penalties and a $450,000 charge for Globus CEO David Paul.
“Firms can’t simply choose to sell devices that FDA has found are not safe and effective,” Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices & Radiological Health, said in prepared remarks. “We took action against Globus Medical to protect patients and we are pleased with the outcome.”
Globus filed for 510(k) clearance for its NuBone bone graft device in January 2009, but the FDA denied the bid on the grounds that the product wasn’t substantially equivalent to anything else on the market.
Audubon, Pa.-based Globus continued to sell NuBone products despite receiving a “not substantially equivalent” letter in December 2009, according to an FDA release. The breach was discovered during a September 2010 inspection.
“This company ignored previous warnings by the FDA and continued to produce and distribute unapproved medical devices,” Dara Corrigan, associate commissioner for regulatory affairs, said in prepared remarks. “By taking this enforcement action, the FDA is demonstrating its commitment to protecting the public from the dangers of unapproved devices.”
Globus Medical declined to comment.