Products: orthopedic-robot, neuro-robot. Risk band: Elevated RobotRisk index 20.2/100 (incidents/exposure, time-weighted) · 94th percentile of 162 medical robotics companies.
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. The index of 19.1 and 93.8th percentile place the company in the elevated band relative to medical-robotics peers. The pattern spans a device-quality-system finding and a hardware-component recall on the same platform, with no injury or fatality entries recorded.
| Sev | Date | Type | Location | Incident | Source |
|---|---|---|---|---|---|
| S3 | 08/13 2024 |
regulatory | — | FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot | RAPS / MassDevice |
| S3 | 02/14 2024 |
recall | — | FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes · ExcelsiusGPS Cannula A, 9mm x 250mm, C… | openFDA enforcement |