FDA recall record · openFDA

Globus Medical, Inc.

6 FDA recalls on record (2023–2025) — 6 device. 6 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the 3

Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficu 1

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter 1

A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workf 1

Recalls

ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100 Class I 2023-12-07 MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S; Class II 2025-04-03 ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844 Class II 2023-12-15 Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the Ex Class II 2023-12-11 Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices w Class II 2023-12-11 Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices Class II 2023-12-11

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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