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U.S. Department of Health and Human Services

Class 1 Device Recall ExcelsiusGPS

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  Class 1 Device Recall ExcelsiusGPS see related information
Date Initiated by Firm December 07, 2023
Date Posted January 18, 2024
Recall Status1 Open3, Classified
Recall Number Z-0642-2024
Recall Event ID 93647
510(K)Number K211616  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Code Information UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109
Recalling Firm/
Manufacturer		 Globus Medical, Inc.
2560 General Armistead Ave
Audubon PA 19403-5214
For Additional Information Contact
610-930-1800
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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 recall@globusmedical.com.
Quantity in Commerce 9
Distribution Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = Globus Medical Inc.
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