Globus Medical, Inc. ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Brand
Globus Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Globus Medical, Inc. is recalling ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 due to A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate nav. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
Recommended Action
Per FDA guidance
The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at recall@globusmedical.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, MT, SC, WA
Page updated: Jan 10, 2026