Globus Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
29 (1 Class I)
510(k) Clearances
169
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-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-0995-2024Class IIGlobus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement December 11, 2023
Z-0642-2024Class IExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100December 7, 2023
Z-2854-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿July 22, 2020
Z-2863-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿July 22, 2020
Z-2855-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿July 22, 2020
Z-2862-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿July 22, 2020
Z-2851-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿July 22, 2020
Z-2857-2020Class IIALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿July 22, 2020
Z-2859-2020Class IIALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 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-2865-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 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-2870-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿July 22, 2020
Z-2868-2020Class IIALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿July 22, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
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
K232318VICTORY™ Lumbar Plate SystemOctober 31, 2023
K231333STRETTO™ Cable SystemAugust 4, 2023
K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsAugust 3, 2023