RobotRisk › Medical robotics › Globus Medical

Globus Medical

Products: orthopedic-robot, neuro-robot. Risk band: Elevated RobotRisk index 33.6/100 (severity- and time-weighted incidents) · ranked 8 of 25 among Medical robotics companies with incidents (173 tracked).

Analyst brief

The record contains two entries tied to the ExcelsiusGPS surgical robot platform: an FDA warning letter citing quality-system and medical-device-reporting violations, and an earlier Class II recall of a cannula component used with the system. Both entries carry severity 3 and are both regulator-driven, indicating sustained compliance scrutiny of one product line rather than an isolated action. Globus Medical's index of 33.6 ranks 8 of 25 companies in Medical robotics with incident history. The pattern spans a device-quality-system finding and a hardware-component recall on the same platform, with no injury or fatality entries recorded.

Risk index

33.6/100RobotRisk index

22.1/100Median index across the 25 Medical robotics companies with incident history (173 tracked, 148 with none)

8 of 25Rank in Medical robotics (of 25 with incident history)

ElevatedRisk band

Incident timeline

Comparisons over time

Per-type breakdown

Incident type	Unique incidents	Share
regulatory	1	50%
recall	1	50%

Unique incident list

2 unique incidents on file for this company.

Sev	Date	Type	Location	Incident	Source
S3	13 Aug 2024	regulatory	—	FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot	RAPS / MassDevice
S3	14 Feb 2024	recall	—	FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes · ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball	openFDA enforcement