Z-0642-2024Class I

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

Name: Z-0642-2024 ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Creator: Globus Medical, Inc.
Published: 2023-12-07
License: https://open.fda.gov/license/

Globus Medical, Inc. / initiated 2023-12-07 / Open, Classified / root cause: design

FDA source

Globus Medical, Inc. began a recall of ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 on 2023-12-07. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0642-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-18
Recalling firm: Globus Medical, Inc.
Product: ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified affected customers through URGENT Medical Device Recall Notificatnoi letters dated December 7, 2023. Customers are instructed to immediately return the Flat Panel Fluoroscopy Registration Fixture. For questions related to this recall, please contact Globus Medical Complaint Handling Unit at [email protected].
Quantity in commerce: 9
Distribution: Domestic distribution to the following states: CA, CO, MT, SC, WA. International distribution to Germany and UK.
Product codes and lots: UDI-DI 00193982465155 Serial Numbers FPFF-0101 FPFF-0102 FPFF-0103 FPFF-0104 FPFF-0105 FPFF-0106 FPFF-0107 FPFF-0108 FPFF-0109

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0642-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0642-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code OLO

K211616Class IIExcelsiusHubGlobus Medical, Inc. / cleared 2021-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)