Globus receives warning letter over spine navigation robot (MedTechDive)
Globus Medical received an FDA warning letter related to its ExcelsiusGPS robotic navigation system for spine surgeries. Retrieved from Globus Medical on August 14, 2024
The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS system malfunctioned.
Dive Brief:
Globus Medical received a Food and Drug Administration warning letter after inspectors found quality system violations at a plant that makes a surgical robot.
The FDA, which published ...
