Lucero Medical's Spinal Fusion Device Draws FDA Warning Letter
3/29/2012 8:14:19 AM
Spinal device company Lucero Medical has received a warning letter from the U.S. Food and Drug Administration, primarily over documentation and quality-control issues. Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium mesh device that’s implanted in the spine to replace collapsed or diseased vertebrae. The device, called the Enduramesh, is designed to aid in spinal fusion. The warning letter specified eight violations uncovered during inspections of Lucero’s facilities. The violations range from failure to establish procedures for the handling of complaints to failure to maintain device history records to failure to implement design control procedures.