ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
This recall is currently active, issued January 18, 2024. It was issued by Globus Medical, Inc..
- Company
- Globus Medical, Inc.
- Recall Initiated
- December 7, 2023
- Posted
- January 18, 2024
- Recall Number
- Z-0642-2024
- Quantity
- 9
- Firm Location
- Audubon, PA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Root Cause
Device Design
Action Taken
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.