Spineart
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED FDA SRN CH-MF-000015664
- Devices
- 7,693
- Registrations
- EUDAMEDFDA
- FDA recalls
- 134 ongoing
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
Catalogue
Search and filter all 7,693 devicesShowing 1-50 of 7,693
Company details
- EUDAMED SRN
- CH-MF-000015664
- EU VAT number
- CHE-112.355.249
- EUDAMED status
- Active
- EUDAMED registered name
- Spineart SA
- Registered address
- 3, chemin du pré-fleuri, 1228, PLAN-LES-OUATES, Switzerland
- Website
- www.spineart.com
- info@spineart.com
- Phone
- +41225701200
- PRRC contact
- Xavier DE BUCHERE
FDA recalls
Recalls initiated per year
- 2017 7
- 2018 0
- 2019 1
- 2020 0
- 2021 1
- 2022 0
- 2023 1
- 2024 1
- 2025 2
- 2026 0
2025
- 30 Jun 2025 Z-2279-2025 Class II Ongoing Cannulated fenestrated polyaxial screws may be incorrectly labeled
- 30 Jun 2025 Z-2280-2025 Class II Ongoing Cannulated fenestrated polyaxial screws may be incorrectly labeled
2024
- 15 Mar 2024 Z-1758-2024 Class II Ongoing 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
2023
- 16 Mar 2023 Z-1426-2023 Class II Ongoing 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.
2021
- 9 Apr 2021 Z-1975-2021 Class II Terminated Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
2019
- 5 Feb 2019 Z-0546-2020 Class III Terminated Inner blister pack label is incorrect and does not match the correct external box label.
2017
- 27 Nov 2017 Z-0336-2018 Class II Terminated 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.
- 27 Nov 2017 Z-0337-2018 Class II Terminated 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.
- 27 Nov 2017 Z-0338-2018 Class II Terminated 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.
- 27 Nov 2017 Z-0339-2018 Class II Terminated 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.
Show all 13 recalls
2017
- 27 Nov 2017 Z-0340-2018 Class II Terminated 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.
- 27 Nov 2017 Z-0341-2018 Class II Terminated 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.
- 27 Nov 2017 Z-0342-2018 Class II Terminated 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 establishments
- Spineart SA Plan-les-Ouates · CH FEI 3007728266
Frequently asked questions
How many devices does Spineart have in the registry?
The registry currently lists 7693 devices for Spineart. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spineart's devices?
Among its 50 most recently registered devices, Spineart has devices listed in EUDAMED (50 devices).
What risk classes do Spineart's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Spineart's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
Are there FDA recall records for Spineart?
FDA recall records list 13 recalls initiated by Spineart, the most recent initiated on 30 Jun 2025. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Spineart in the registry?
The most recently registered devices listed for Spineart include PERLA® - CANNULATED SMOOTH SHANK SCREW, PERLA® - CANNULATED CC PREFERRED ANGLE SCREW, PERLA® - CANNULATED POLYAXIAL SCREW and PERLA® - CANNULATED ML PREFERRED ANGLE SCREW.
Which FDA establishments are linked to Spineart?
1 FDA establishment is linked to Spineart in the registry; they are listed on the company page.