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icotec AG

Active in EUDAMED

Switzerlandfrom SRN EUDAMED FDA SRN CH-MF-000026833 FEI 3006493760

Devices
407
Registrations
EUDAMEDFDA
FDA recalls
32 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls
Authorised rep.
icotec Medical GmbHDE

What icotec AG makes

icotec AG manufactures reusable device sterilization and disinfection containers, spinal bone screws that are non-bioabsorbable, and related surgical instruments such as handles, screwdrivers, probes, templates, distractors/compressors, pedicle testers, and cement cannula sleeves. These products are used in spinal fixation procedures and include components made from carbon/PEEK materials, such as pedicle system screws, rods, and cages for lumbar and cervical applications.

The manufacturer's devices are classified as Class I, Class II, Class IIa, and Class IIb, and are listed in the EUDAMED database and the FDA 510(k) registry. icotec AG is based in Switzerland (CH).

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue407

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
CH-MF-000026833
FDA FEI number
3006493760
DUNS number
480789465
EUDAMED status
Active
EUDAMED registered name
icotec ag
Registered address
12, Industriestrasse, 9450, Altstätten, Switzerland
Phone
+41717570000
PRRC contact
Ramon Hüppi(public in EUDAMED)

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by icotec AG, the earliest on 2022-11-03 and the most recent on 2023-11-28. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 1
  • 2023 2
  • 2024 0
  • 2025 0
  • 2026 0

  • 2023

    • 28 Nov 2023 Z-0700-2024 Class II Ongoing icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently. Distribution: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA Submission number: K222789
    • 28 Nov 2023 Z-0701-2024 Class II Ongoing icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently. Distribution: US: AZ. MI, OH, CA, CO, TX, NY, NC, DE, PA Submission number: K222789

  • 2022

    • 3 Nov 2022 Z-0728-2023 Class II Terminated During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm. Distribution: US Nationwide distribution in the state of GA. Submission numbers: K190545, K193423, K200596

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Icotec US

Frequently asked questions

How many devices does icotec AG have in the registry?

The registry currently lists 407 devices for icotec AG. Devices recorded under merged duplicate company entries are counted once.

Which registries list icotec AG's devices?

Among its 50 most recently registered devices, icotec AG has devices listed in EUDAMED (50 devices).

What risk classes do icotec AG's devices fall under?

Among its 50 most recently registered devices, the classes recorded for icotec AG's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.

Are there FDA recall records for icotec AG?

FDA recall records list 3 recalls initiated by icotec AG, the most recent initiated on 28 Nov 2023. 2 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 icotec AG in the registry?

The most recently registered devices listed for icotec AG include VADER®os Pedicle System, Navigated Cannulated Tap, Ø 6,5 mm, VADER® Pedicle System, VADER®os Screw, Carbon/PEEK, Polyax., Fen., Ø 5.5 × 25 mm, icotec Cervical Cage, Lordotic, ↕ 10 mm ↔ 16 mm and VADER® Pedicle System, VADER®os Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 × 30 mm.

Which FDA establishments are linked to icotec AG?

1 FDA establishment is linked to icotec AG in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.