Skip to content

Ortho Solutions GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED FDA SRN DE-MF-000005535

Devices
14
Registrations
EUDAMEDFDA
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA establishment, FDA recalls

Catalogue14

Newest first, rows 1-14 of 14

Search and filter all 14 devices
Skip device list

  • Biegevorrichtung Ref 6990-1210

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1252

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1214

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Adapter / Kupplung Ref 6990-1850

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1212

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1240

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1250

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1244

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1260

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1232

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1220

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1230

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Biegevorrichtung Ref 6990-1242

    Active Regimes: CE MDR Registry: EUDAMED Class:I

  • Schlitzhammer Ref 6956-0050

    Active Regimes: CE MDR Registry: EUDAMED Class:I

Rows 1-14 of 14

Company details

EUDAMED SRN
DE-MF-000005535
EU VAT number
DE220578899
EUDAMED status
Active
EUDAMED registered name
Ortho Solutions GmbH
EUDAMED abbreviated name
Ortho Solutions GmbH
Registered address
2, Eltastraße, 78573, Wurmlingen, Germany
Phone
+49 7461 963570
PRRC contact
Nadine Koch(public in EUDAMED)

FDA recalls4

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

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

2 initiated before 2017

  • 2017

    • 10 Oct 2017 Z-0967-2018 Class II Terminated Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market. Distribution: U.S. Submission number: K163489
    • 19 Apr 2017 Z-2780-2017 Class II Terminated There is a material mislabeling of the AFN End Cap.via FDA establishment Ortho Solutions Inc Distribution: US distribution to MD, NY & PA Submission number: K121575

  • 2016

    • 21 Jul 2016 Z-2835-2016 Class II Terminated Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.via FDA establishment Ortho Solutions Inc Distribution: US Distribution Submission number: K111678

  • 2015

    • 14 Jul 2015 Z-0026-2016 Class II Terminated Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ Distribution: US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA. Submission number: K141784

FDA establishments1

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

  • Ortho Solutions Inc Nashville, TN · US FEI 3022270316

From the company website

Read 18 Sep 2026

Ortho Solutions produces exclusively in Germany. Our Wurmlingen site near Tuttlingen is located in the world’s most important centre for medical technology. The reliable partner in the field of traumatology, orthopedics and veterinary medicine. Ortho Solutions produces medical orthopedics and traumatological implants at the Wurmlingen site near Tuttlingen.

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does Ortho Solutions GmbH have in the registry?

The registry currently lists 14 devices for Ortho Solutions GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ortho Solutions GmbH's devices?

Among its 14 most recently registered devices, Ortho Solutions GmbH has devices listed in EUDAMED (14 devices).

What risk classes do Ortho Solutions GmbH's devices fall under?

Among its 14 most recently registered devices, the classes recorded for Ortho Solutions GmbH's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for Ortho Solutions GmbH?

FDA recall records list 4 recalls initiated by Ortho Solutions GmbH, the most recent initiated on 10 Oct 2017. 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 Ortho Solutions GmbH in the registry?

The most recently registered devices listed for Ortho Solutions GmbH include Biegevorrichtung, Adapter / Kupplung and Schlitzhammer.

Which FDA establishments are linked to Ortho Solutions GmbH?

1 FDA establishment is linked to Ortho Solutions GmbH in the registry; they are listed on the company page.

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