Globus Medical receives FDA warning letter for ExcelsiusGPS complaint procedures

GLOBUS MEDICAL INC

FDA warning letter cites non-conformities in complaint handling, trending, risk reconciliation, and MDR reporting for the ExcelsiusGPS robotic system.
Inspection occurred Feb 15–Mar 7, 2024; company says deficiencies in response letters to the Form 483.
No safety concerns with use of the system or manufacturing process were identified.
Company has taken corrective actions and believes issues can be resolved without material financial impact.
Until resolution, additional regulatory action may be taken without further notice.

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