Sanofi Genzyme Corp.
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sanofi Genzyme Corp. makes
Sanofi Genzyme Corp. manufactures SYNVISC, a hyaluronic acid-based injectable product designed for intra-articular use in patients with osteoarthritis of the knee.
The company’s portfolio is regulated under Class III devices in the US, with SYNVISC listed under a Premarket Approval (PMA) application with the FDA. The manufacturer is based in the United States.
Catalogue
Synvisc Ref P940015
Regimes: PMA Registry: PMA
FDA recalls
FDA recall records list 1 recall initiated by Sanofi Genzyme Corp., initiated on 2017-12-11. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination. 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 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 11 Dec 2017 Z-0607-2018 Class II Terminated Contamination with Methylbacterium thiocyanatum
Frequently asked questions
How many devices does Sanofi Genzyme Corp. have in the registry?
The registry currently lists 1 device for Sanofi Genzyme Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sanofi Genzyme Corp.'s devices?
Among its 1 most recently registered device, Sanofi Genzyme Corp. has devices listed in FDA PMA (1 device).
What risk classes do Sanofi Genzyme Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Sanofi Genzyme Corp.'s devices are Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Sanofi Genzyme Corp.?
FDA recall records list 1 recall initiated by Sanofi Genzyme Corp., the most recent initiated on 11 Dec 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 Sanofi Genzyme Corp. in the registry?
The most recently registered devices listed for Sanofi Genzyme Corp. include SYNVISC.