Globus Medical, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Orthopedic Stereotaxic InstrumentOLO727
• Orthosis, Spondylolisthesis Spinal FixationMNH532
• Appliance, Fixation, Spinal Intervertebral BodyKWQ198
• Orthopedic Manual Surgical InstrumentLXH169
• Thoracolumbosacral Pedicle Screw SystemNKB123
• Spinal Vertebral Body Replacement DeviceMQP105
• Intervertebral Fusion Device With Bone Graft, LumbarMAX102
• Posterior Metal/Polymer Spinal System, FusionNQP62
• Appliance, Fixation, Spinal InterlaminalKWP55
• Prosthesis, Intervertebral DiscMJO51

Recent recalls

• 2025-04-23Open, ClassifiedNonconforming Material/Component

  MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

  Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

• 2024-02-07Open, ClassifiedDevice Design

  ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844

  Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.

• 2024-02-06Open, ClassifiedPackage design/selection

  Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S

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

• 2024-02-06Open, ClassifiedPackage design/selection

  Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S

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

• 2024-02-06Open, ClassifiedPackage design/selection

  Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S

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

• 2024-01-18Open, ClassifiedDevice Design

  ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100

  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.

• 2020-08-22TerminatedNonconforming Material/Component

  ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8 (sterile)

  Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

• 2020-08-22TerminatedNonconforming Material/Component

  ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8

  Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

• 2020-08-22TerminatedNonconforming Material/Component

  ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8

  Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

• 2020-08-22TerminatedNonconforming Material/Component

  ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8

  Specific lots of ALTERA implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.