RegWardenFDA facility compliance records
Company

NUVASIVE, INC.

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

Recalls by year

FDA actions on record by year2009: 1 recalls; 2020: 2 recalls; 2022: 3 recalls1’09’10’11’12’13’14’15’16’17’18’192’20’213’22’23’24’25’26
  • Recalls (6)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2022-11-10
    Potential that insert will be unable to disengage from the vertebral body replacement device/implant
  • Class IIIOngoing2022-07-19
    Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
  • Class IIOngoing2022-06-20
    Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
  • Class IITerminated2020-06-10
    The NVM5 EMG Module kit intended for intraoperative neurophysiologic monitoring during spinal surgery contains incorrect component, part number 1715945, SSEP harness instead of the the correct part number 1747065, NVM5 Harness, Gen 3.5 EM. This issue can result in delay in thera…
  • Class IITerminated2020-02-13
    Post-implantation separation of an actuator end cap component that may expose internal components of the actuator, which could lead to hastened degeneration of the internal components and egress of Titanium alloy wear debris and resultant localized tissue discoloration.
  • Class IITerminated2009-01-05
    The tulip portion of the screw assembly can disengage from the shank after implantation.

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. “NUVASIVE, 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-9036345-nuvasive-inc/

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