Class I

Medical Device Recall: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Globus Medical, Inc. · December 7, 2023

Reason for Recall

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.

Distribution

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

States Affected

CA, CO, MT, SC, WA

Quantity Affected

9

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0642-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Globus Medical, Inc. Medical Device Recall: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 | SafeCheck