Recall archive / FDA device enforcement
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 — FDA record Z-0642-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 7, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Reason
- 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.
- Classification
- Class I
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 9
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0642-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Dec 7, 2023
- Center classification date
- Jan 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.