RegWardenFDA facility compliance records
Company

Globus Medical, Inc

6 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2020: 1 recalls; 2023: 3 recalls; 2025: 1 recalls1’13’14’15’16’17’18’191’20’21’223’23’241’25’26
  • Recalls (6)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-04-03
    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.
  • Class IIOngoing2023-12-15
    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-con…
  • Class IIOngoing2023-12-11
    Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
  • Class IOngoing2023-12-07
    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.
  • Class IITerminated2020-07-22
    Specific lots of ALTERA® implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
  • Class IITerminated2013-08-28
    The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Globus Medical, Inc — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10030390-globus-medical-inc/

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