FDA Issues Class I Recall Notice for Globus Medical's Orthopedic Surgical Robot with Calibration Errors That Have Injured 2 People

The U.S. Food and Drug Administration (FDA) recently issued a notice requesting Globus Medical to recall the Flatbed Fluoroscopic Positioning Fixture for its ExcelsiusGPS Orthopedic Surgical Robot. The reason for this recall is that the device has a calibration error that could cause users to suffer serious, even life-threatening injuries during use.The FDA has classified this recall as Class I, which is the most serious of the recall levels.

Details of the recalled products are listed below:

Product Name: ExcelsiusGPS

Product Code: OLO

Part Number: 6203.2100

Ship Date: July 1, 2023 to November 30, 2023

Number of devices recalled in the U.S.: 7 units

Company Initiated Recall Date: December 7, 2023

In this recall, Globus Medical discovered that its flatbed fluoroscopy positioning fixture had errors in the calibration process that could lead to inaccurate navigation, which could result in misplacement of the device and harm to patients. When the fixture is used with the ExcelsiusGPS to input medical images, there is a risk that the patient image will not be properly aligned with the computer-aided design (CAD) model. This can lead to misplacement of implants or devices, which may result in a variety of complications including tissue damage, dural tears, cerebrospinal fluid leaks, nerve irritation, loss of sensation, paralysis, vascular injury, visceral injury, and vertebral root fractures.

To address this issue, Globus Medical has sent an emergency medical device recall notice to all affected customers requesting immediate return of the fixtures to the company and feedback on the adverse events. The company will take back the affected products and re-test and validate to recalibrate the flat panel fluoroscopy positioning fixtures. Two people have been reportedly injured as a result, but no deaths have been reported.

There are three levels of FDA recalls: a Class I recall, which represents a problem with the product that could lead to serious health problems or death, is the most serious level of recall. a Class II recall, which indicates that the product may cause a temporary or medically recoverable problem, or that the cause of the recall is unlikely to cause a patient health problem. a Class III recall, which is due to a product violating the FDA's labeling or manufacturing standards, but the use of these products is unlikely to cause health problems.

Globus Medical Company

Globus Medical is a company focused on developing and marketing innovative solutions for spine surgery, with its main product being the spine surgery robot ExcelsiusGPS, which combines a rigid robotic arm and full navigation capabilities into one adaptable platform for precise navigation in spine surgery. The company has not yet entered China.The ExcelsiusGPS® platform is compatible with any spine surgery imaging system, allowing surgeons to visualize, plan and navigate a patient's anatomy in real time.

ExcelsiusGPS Orthopedic Surgical Robot

The ExcelsiusGPS Orthopedic Surgical Robot is an innovative medical device developed by Globus Medical. This robot combines a rigid robotic arm and full navigation capabilities into an adaptable platform for precise navigation during spine surgery.

A key feature of the ExcelsiusGPS platform is its compatibility with any spine surgery imaging system. Surgeons can use this platform to visualize, plan, and navigate a patient's anatomy in real time. This platform offers three optional imaging modalities: intraoperative CT (3D), preoperative CT (3D) and fluoroscopy (2D). With precision monitoring, force sensing technology and active navigation tracking, surgeons can validate the surgical plan and receive real-time navigation feedback throughout the procedure.

In addition, Globus Medical has developed Excelsius3D™, a mobile X-ray system with imaging adaptability, intelligence and automation designed for 2D fluoroscopy, 2D digital radiography and 3D imaging of adult and pediatric patients. The 3-in-1 imaging platform, Excelsius3D™, combines cone-beam CT, fluoroscopy and digital radiography into one unit, eliminating the need for multiple imaging devices throughout the procedure.

The advent of the ExcelsiusGPS orthopedic surgical robot has revolutionized spine surgery, allowing for more precise and safer procedures that have greatly improved surgical outcomes and patient quality of life. However, the device has recently been issued a Class I recall by the FDA due to a calibration error in the flat panel fluoroscopy positioning fixture.