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RobotRisk / Globus Medical / 2024-08-13
medical robotics · regulatory

FDA warns Globus Medical over QSR/MDR violations tied to ExcelsiusGPS surgical robot

S3 · 08/13
2024 · Globus Medical

Record

CompanyGlobus Medical
Categorymedical robotics
Typeregulatory
Date08/13
2024
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
Scale-
Confidencemedium
VerificationYes - adversarially checked against the cited source
SourceRAPS / MassDevice (via Google News)

What happened

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.

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