ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part… recallZ-0642-2024 · Globus Medical, Inc. · initiated Dec 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Globus Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-0642-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2023
- Posted by the FDA
- Jan 18, 2024
- Recalling firm
- Globus Medical, Inc.
- Quantity
- 9
- Product code
- OLO
- FDA submissions
- K211616
- Distribution
- Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Product description
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Code information (models, lots, serial numbers)
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXCELSIUSHUB 6203.2100Globus Medical, Inc. · Orthopedic stereotaxic instrument1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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