According to the FDA, a December 7, 2023 recall of Globus Medical, Inc.’s ExcelsiusGPS Flat Panel Fluoroscopy Registration Fixture has been identified as Class I, the most serious type, because use of the device may lead to major injuries or death.
The now-recalled ExcelsiusGPS Flat Panel Fluoroscopy Fixture is a component in ExcelsiusGPS, “a surgical guidance system” that pairs robotic technology and navigation for use in spine surgery. Surgeons rely on the system during spinal procedures for accurate placement of implants. The ExcelsiusGPS Flat Panel Fluoroscopy Fixture component of the system is indicated to input medical images during those procedures.
Initiated by Globus Medical, Inc. on December 7, 2023, the recall by removal covers seven (7) devices that were distributed across the U.S. between July 1, 2023 and November 30, 2023. The company took action after determining that a calibration process error in the ExcelsiusGPS Flat Panel Fluoroscopy Fixture may compromise the integrity of the system’s navigation, which poses a risk of “device misplacement and patient harm.”
Officials say that use of the potentially compromised fixture with the ExcelsiusGPS in inputting medical images may result in the patient’s image not corresponding with the computer-assisted design (CAD) model, which could then lead to the misplacement of implants and instruments.
Healthcare providers who use the ExcelsiusGPS Flat Panel Fluoroscopy Fixture during spinal surgical procedures, as well as patients who anticipate spinal surgery in which the component will be used, are advised that a misplacement could result in the following complications:
- tissue damage
- dural tear
- cerebrospinal fluid leak
- nerve irritation
- loss of sensation
- paralysis
- vascular injury
- visceral injury
- pedicle fracture
Because the component’s calibration error was not discovered until after the devices had already been distributed, the company has received two (2) reports of related injuries to date. No deaths have been recorded in connection with the problem.
On the day of the recall announcement (December 7, 2023), all affected Globus Medical, Inc. customers were sent a communication labeled “URGENT: Medical Device Recall Notification” with the following requests:
- Return the Flat Panel Fluoroscopy Registration Fixture to Globus Medical as soon as possible.
- Report any issues or adverse events that can be traced to use of the device.
All Flat Panel Fluoroscopy Registration Fixtures returned to the company is set to be quarantined pending a “test method validation” to recalibrate the components.
U.S. customers may direct any recall-related questions to the Globus Medical Complaint Handling Unit via email at recall@globusmedical.com.
As the FDA continues to monitor this recall, healthcare professionals and consumers alike are encouraged to report related issues to the agency’s MedWatch program.
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