Novosource, Inc.
United StatesFDA applicant, unverified
- Devices
- 901
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Novosource, Inc. makes
Novosource, Inc. manufactures reusable and prefabricated orthopedic implants for joint replacement procedures, including knee and hip prostheses. Their portfolio includes trial components for knee and acetabulum implants, as well as total knee systems with posterior-stabilized and cruciate-retaining designs. The company also produces press-fit hip femur prostheses and reusable joint prosthesis implantation kits.
The devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
Catalogue
Search and filter all 901 devicesShowing 1-50 of 901
FDA recalls
FDA recall records list 1 recall initiated by Novosource, Inc., initiated on 2024-09-19. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use and packaging. 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 19 Sep 2024 Z-0483-2025 Class II Ongoing Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted
Frequently asked questions
How many devices does Novosource, Inc. have in the registry?
The registry currently lists 901 devices for Novosource, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Novosource, Inc.'s devices?
Among its 50 most recently registered devices, Novosource, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Novosource, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Novosource, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Novosource, Inc.?
FDA recall records list 1 recall initiated by Novosource, Inc., the most recent initiated on 19 Sep 2024. 1 of them is 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 Novosource, Inc. in the registry?
The most recently registered devices listed for Novosource, Inc. include NovoKnee Total Knee System 3301-1012, NovoHip Total Hip System 1400-1600, Novosource Total Hip System 1280-4628 and NovoHip Total Hip System 1100-0009.