Facility

ALPES CN SAS

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

Key facts

6recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3037407500
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	356 Rue de la Tour Reignier-Esery Haute-Savoie, FR 74930
Registration status	Active · expires 2026
Parent company	SPINEART SA (owner-operator 10028947)
Brand names	ROMEO

Activity by year

Recalls (6)

Devices registered here (3)

Orthosis, Spinal Pedicle Fixation
Product code MNI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Orthosis, Spondylolisthesis Spinal Fixation
Product code MNH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3070
Appliance, Fixation, Spinal Interlaminal
Product code KWP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3050

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. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ALPES CN SAS (FEI 3037407500) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3037407500-alpes-cn-sas/

Not open yet

Alerts for ALPES CN SAS

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.