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RobotRisk / Globus Medical / 2024-02-14
medical robotics · recall

FDA Class II recall: ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes

S3 · 02/14
2024 · Globus Medical

Record

CompanyGlobus Medical
Categorymedical robotics
Typerecall
Date02/14
2024
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
SeverityS3 (recall, enforcement, or fleet-wide fault)
ScaleExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball
Confidencehigh
VerificationYes - adversarially checked against the cited source
SourceopenFDA enforcement

What happened

FDA enforcement record (Class II, recall Z-1007-2024): Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-con

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