RobotRisk › Globus Medical › 13 Aug 2024
FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot
S3 · 13 Aug 2024 · Globus Medical
Record
| Company | Globus Medical |
| Industry | Medical robotics |
| Type(s) | regulatory |
| Date | 13 Aug 2024 (day precision) |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | (recall, enforcement, or fleet-wide fault) |
| Scale | not documented |
| Confidence | medium |
| Verified flag | Yes - independently re-checked against the cited source |
Summary
FDA warning letter (dated July 15, 2024) cited Globus Medical for inadequate CAPA analysis of dozens of misplaced-screw incidents involving its ExcelsiusGPS robotic spine navigation system, and for delayed MDR reporting of a malfunction (known since 2019, reported March 2024, beyond the 30-day requirement); stock declined on the news.
Primary source
RAPS / MassDevice (via Google News)
Publisher: RAPS / MassDevice (via Google News) · Retrieved: 2026-09-16
Supporting source rows (1)
| Date | Supporting source row | Publisher | Link |
|---|---|---|---|
| 13 Aug 2024 | FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot | RAPS / MassDevice (via Google News) | RAPS / MassDevice |
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