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Globus Medical, Inc.

FDA Regulatory Profile

Globus Medical, Inc. appears in FDA public data with 29 recalls — including 1 Class I (most serious) —, 172 510(k) clearances, 23 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-1657-2025, Class II) was initiated on April 3, 2025. Its most recent 510(k) clearance was granted on May 7, 2026.

Summary

Total Recalls
29 (1 Class I)
510(k) Clearances
172
Inspections
23
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1657-2025Class IIMAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;April 3, 2025
Z-1007-2024Class IIExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844December 15, 2023
Z-0995-2024Class IIGlobus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement December 11, 2023
Z-0996-2024Class IIGlobus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placementDecember 11, 2023
Z-0997-2024Class IIGlobus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranialDecember 11, 2023
Z-0642-2024Class IExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100December 7, 2023
Z-2862-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿July 22, 2020
Z-2860-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿July 22, 2020
Z-2851-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿July 22, 2020
Z-2861-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿July 22, 2020
Z-2869-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿July 22, 2020
Z-2871-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿July 22, 2020
Z-2867-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿July 22, 2020
Z-2850-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)July 22, 2020
Z-2856-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿July 22, 2020
Z-2868-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿July 22, 2020
Z-2858-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿July 22, 2020
Z-2864-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿July 22, 2020
Z-2853-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿July 22, 2020
Z-2855-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿July 22, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization SMay 7, 2026
K253401SCRIPT™ Implant SystemApril 29, 2026
K261043AUTOBAHN™ Nailing SystemApril 24, 2026
K252166RIB LINK™ Fixation SystemFebruary 26, 2026
K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)December 22, 2025
K250599ExcelsiusGPS™ InstrumentsNovember 5, 2025
K251161ANTHEM® Fracture SystemAugust 18, 2025
K241525ExcelsiusXR™July 8, 2025
K243456ONVOY™ Acetabular SystemJune 6, 2025
K243814NuVasive Pulse SystemJanuary 10, 2025
K243671ExcelsiusGPS® InstrumentsDecember 20, 2024
K241260ACTIFY™ Unicondylar Knee SystemDecember 6, 2024
K234035COSINE™ SpacerSeptember 6, 2024
K240669ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee SystemJune 20, 2024
K240721ExcelsiusFlex™June 14, 2024
K240947TENSOR® Suture Button SystemJune 3, 2024
K240568DuraPro™ Oscillating SystemApril 29, 2024
K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsMarch 14, 2024
K233638VERZA™ High Speed DrillsFebruary 9, 2024
K233735ADIRA™ Lateral Plate SystemJanuary 25, 2024

FDA data resources