RegWardenFDA facility compliance records
Facility

NUVASIVE, INC.

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

Activity by year

FDA actions on record by year2009: 1 recalls; 2017: 1 inspections; 2019: 1 inspections; 2020: 2 recalls; 2022: 3 recalls; 2024: 1 inspections1’09’10’11’12’13’14’15’161’17’181’192’20’213’22’231’24’25’26
  • Recalls (6)
  • Inspections (3)

Devices registered here (2)

  • Spinal Vertebral Body Replacement Device - Cervical
    Product code PLR (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060
  • Spinal Vertebral Body Replacement Device
    Product code MQP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060

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.

FDA inspections (3)

  • NAI2024-01-18
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2019-12-09
    No Action Indicated · Compliance: Devices
  • NAI2017-05-31
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NUVASIVE, INC. (FEI 3009144915) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009144915-nuvasive-inc/

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