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  5. Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error
  1. Medical Device Recalls

Globus Medical, Inc. Recalls ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture Due to a Calibration Error

Please be aware, this recall is a correction, not a product removal.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product (Include the following information)

  • Product Names: ExcelsiusGPS
  • Product Codes: OLO
  • Part number: 6203.2100
  • Distribution Dates: July 1, 2023 to November 30, 2023
  • Devices Recalled in the U.S.: 7
  • Date Initiated by Firm: December 7, 2023

Device Use

ExcelsiusGPS is a surgical guidance system used in spine surgery, combining robotic technology and navigation. It's designed to assist surgeons in accurately placing implants during spinal procedures.

The ExcelsiusGPS Flat Panel Fluoroscopy Fixture is a specific component associated with the ExcelsiusGPS surgical guidance system used for inputting medical images during spinal procedures.

Reason for Recall

Globus Medical, Inc. is recalling, by removal, the ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture, a fixture utilized with their ExcelsiusGPS, a stereotaxic navigation device. This recall is being conducted because a calibration process error associated with the ExcelsiusGPS Flat Panel Fluoroscopy Fixture may cause a loss of navigation integrity, which may result in device misplacement and patient harm.

When this fixture is used with ExcelsiusGPS to input medical images, there's a chance that the patient's image doesn't align correctly with the computer-assisted design (CAD) model, causing implants or instruments to be misplaced. The root cause is associated with a calibration algorithm error that may affect the accuracy of implant placement. This calibration error was not detected prior to distribution.

This misplacement could lead to various complications such as tissue damage, dural tear, cerebrospinal fluid leak, nerve irritation, loss of sensation, paralysis, vascular injury, visceral injury, and pedicle fracture.

There have been 2 reported injuries. There have been no reports of death.

Who May be Affected

  • Healthcare providers who perform spinal surgical procedures using the ExcelsiusGPS Flat Panel Fluoroscopy Fixture.
  • People who are having spinal surgery and where the ExcelsiusGPS Flat Panel Fluoroscopy Fixture will be used.

What to Do

On December 7, 2023, Globus Medical, Inc. sent all affected customers an URGENT: Medical Device Recall Notification.

 The letter requested customers to: 

  • Immediately return the Flat Panel Fluoroscopy Registration Fixture to Globus Medical.
  • Report any adverse events believed to be associated with the Flat Panel Fluoroscopy Registration Fixture to Globus Medical.

Affected products will be quarantined and test method validation will be redone to recalibrate the Flat Panel Fluoroscopy Fixtures.

Contact Information

Customers in the U.S. with questions about this recall should contact Globus Medical Complaint Handling Unit at [email protected]

Additional Resources:  

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 
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