RegWardenFDA facility compliance records
Company

SPINEART SA

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

Recalls by year

FDA actions on record by year2017: 1 recalls; 2019: 1 recalls; 2021: 1 recalls; 2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls1201720181201920201202120221202312024120252026
  • Recalls (6)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-06-30
    Cannulated fenestrated polyaxial screws may be incorrectly labeled
  • Class IIOngoing2024-03-15
    Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew
  • Class IIOngoing2023-03-16
    JULIET Lateral Lumbar Ti-Life Plate, a component of the JULIET Ti Lateral Lumbar Cage, may disassemble during the preparation stage before implantation, or during surgery when removing the implant holder, which could cause surgical delay.
  • Class IITerminated2021-04-09
    Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
  • Class IIITerminated2019-02-05
    Inner blister pack label is incorrect and does not match the correct external box label.
  • Class IITerminated2017-11-27
    Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.

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. “SPINEART SA — 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-10028947-spineart-sa/

Not open yet

Alerts for SPINEART SA

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.