Facility

SPINEART SA

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

Key facts

6recalls · worst Class II

1inspections · worst NAI

—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)	3007728266
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	Chemin du Pre-Fleuri 3 Plan-les-Ouates, CH 1228
Registration status	Active · expires 2026
Parent company	SPINEART SA (owner-operator 10028947)
Brand names	Perla TL

Activity by year

Recalls (6)
Inspections (1)

Devices registered here (1)

Dispenser, Cement
Product code KIH (opens in a new tab) · Class I · Orthopedic · 21 CFR 888.4200

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.

FDA inspections (1)

NAI2016-12-08
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.

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. “SPINEART SA (FEI 3007728266) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007728266-spineart-sa/

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