Globus Medical, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0642-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Product Classification:

Class I

Date Initiated: December 7, 2023

Date Posted: January 24, 2024

Recall Number: Z-0642-2024

Event ID: 93647

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.

Status: Ongoing

Product Quantity: 9

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

Distribution Pattern:

Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.

Voluntary or Mandated:

Voluntary: Firm initiated