Globus Medical
Robot types: Ortho robot, Neurosurgical / ablation robot. Risk band: Elevated RobotRisk index 33.3/100 (severity- and time-weighted incidents) · ranked 8 of 25 among Medical robotics companies with incidents (274 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. 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
Products and robot types
Industries: Medical robotics · Sectors: Hospitals and Health Care
Risk is scored per product and robot type: each incident is attributed to the product it names, or to the company's matching robot type.
| Robot type | Share of company risk | Rank within type |
|---|---|---|
| Ortho robot | 100% | 1 of 3 |
| Product | Robot type | Status | Incidents | Index |
|---|---|---|---|---|
| ExcelsiusGPS | Ortho robot | shipping | 2 | 33.3 |
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 |
S3 13 Aug 2024 · regulatory · FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 13 Aug 2024 | 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
| Sev | Date | Supporting source row | Source |
|---|---|---|---|
| S3 | 14 Feb 2024 | FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes | openFDA enforcement |
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