Globus Sent Cautionary Letter for Spine Navigation Robot

The FDA said that although information that “reasonably suggests” the Excelsius GPS device malfunctioned, Globus withheld reporting concerns regarding misplaced screws. The FDA issued a cautionary letter to Globus Medical after its investigators discovered safety breaches at a surgical robot manufacturing facility.

In an article to investors, analysts at RBC Capital Markets stated that as the FDA has not raised any concerns about the safety of the product and no gadgets are being recalled, the risks associated with the letter of caution are controllable.

In February and March, the FDA conducted an inspection of a Globus factory that produces the Excelsius GPS (EGPS) surgical robot. The auditors discovered issues with Globus’ adherence to the standards for healthcare device monitoring and the quality system regulation.

The FDA claims that Globus neglected to initiate investigations under the preventative and remedial procedures in response to reports regarding screws that were misplaced. Globus provided the FDA with information on the frequency of problems with screws inserted between 2017 and 2024. The FDA, however, said that the answer was insufficient as it did not include analysis to ascertain whether part numbers were associated with any trends.