RegWardenFDA facility compliance records
Company

NovApproach Spine, LLC

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

Recalls by year

FDA actions on record by year2022: 1 recalls; 2026: 1 recalls201720182019202020211202220232024202512026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2026-04-23
    Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
  • Class IITerminated2022-10-12
    The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

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. “NovApproach Spine, LLC — 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-10082697-novapproach-spine-llc/

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