FDA Recall
Open, Classified
ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Recall: Z-0642-2024
·
Initiated December 7, 2023
Recall
- Recall Number
- Z-0642-2024
- Event Number
- 93647
- Firm
- Globus Medical, Inc.
- FEI Number
- 3004142400
- Product Code
- OLO
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 7, 2023
- Posted
- January 18, 2024
- Address
- 2560 General Armistead Ave, Audubon, PA, 19403-5214
Description
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.
Action
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].
Distribution
Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Quantity
9