Fx Solutions
FranceFDA applicant, unverified
- Devices
- 1,482
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Fx Solutions makes
FX Solutions manufactures reusable orthopaedic surgical procedure kits, non-sliding bone screws, and shoulder arthroplasty components, including polyethylene reverse shoulder cups, uncoated and coated humeral stems, prefabricated glenoid fossa prostheses, and stem-fixed metallic humeral heads. Their portfolio also includes lateralized and augmented baseplates, cemented reversible shoulder systems, and anatomical shoulder prostheses. Manual surgical instruments for orthopaedic procedures are part of their product line.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. FX Solutions operates from the United States.
Catalogue
Search and filter all 1,482 devicesShowing 1-50 of 1,482
Company details
- DUNS number
- 263076196
- [email protected]
- Phone
- +33474553397
FDA recalls
FDA recall records list 2 recalls initiated by FX SOLUTIONS, initiated on 2018-06-04. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 2
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 4 Jun 2018 Z-2468-2018 Class II Terminated Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Full distribution text
- 4 Jun 2018 Z-2469-2018 Class II Terminated Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Full distribution text
- 4 Jun 2018 Z-2468-2018 Class II Terminated Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.
Frequently asked questions
How many devices does FX SOLUTIONS have in the registry?
The registry currently lists 1482 devices for FX SOLUTIONS. Devices recorded under merged duplicate company entries are counted once.
Which registries list FX SOLUTIONS's devices?
Among its 50 most recently registered devices, FX SOLUTIONS has devices listed in EUDAMED (11 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do FX SOLUTIONS's devices fall under?
Among its 50 most recently registered devices, the classes recorded for FX SOLUTIONS's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for FX SOLUTIONS?
FDA recall records list 2 recalls initiated by FX SOLUTIONS, the most recent initiated on 4 Jun 2018. 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 FX SOLUTIONS in the registry?
The most recently registered devices listed for FX SOLUTIONS include FX V135 Shoulder Prosthesis 951-5614, HUMELOCK 903-4036, HUMELOCK 903-4440 and ORTHOPEDIC MANUAL SURGICAL INSTRUMENT 901-1003.