Home / Recalls / Globus Medical, Inc. / Z-0642-2024

Z-0642-2024 Class I Ongoing

Recalled by Globus Medical, Inc. — Audubon, PA

Recall Details

Product Type
Devices
Report Date
January 24, 2024
Initiation Date
December 7, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9

Product Description

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

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.

Distribution Pattern

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

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

Other recalls by Globus Medical, Inc.

  • Z-1657-2025 Class II — MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; (April 3, 2025)
  • Z-1007-2024 Class II — ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No (December 15, 2023)
  • Z-0996-2024 Class II — Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, prepar (December 11, 2023)
  • Z-0995-2024 Class II — Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, prepara (December 11, 2023)
  • Z-0997-2024 Class II — Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and (December 11, 2023)
  • Z-2854-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿ (July 22, 2020)
  • Z-2852-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ (July 22, 2020)
  • Z-2862-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿ (July 22, 2020)
  • Z-2855-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿ (July 22, 2020)
  • Z-2863-2020 Class II — ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿ (July 22, 2020)