Orthopediatrics Canada Ulc Dba Pega Medical
CanadaFDA applicant, unverified
- Devices
- 1
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Orthopediatrics Canada Ulc Dba Pega Medical makes
The manufacturer produces the Fassier-Duval Telescoping Intramedullary (IM) System, a telescoping rod designed for orthopedic applications such as the treatment of bone deformities.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry. The company is based in Canada.
Catalogue
Fassier-Duval Telescoping IM System Ref K241983
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Orthopediatrics Canada Ulc Dba Pega Medical, initiated on 2024-07-04. By recorded status: 1 ongoing. 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 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 4 Jul 2024 Z-2941-2024 Class II Ongoing During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
Full distribution text
- 4 Jul 2024 Z-2941-2024 Class II Ongoing During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.
Frequently asked questions
How many devices does Orthopediatrics Canada Ulc Dba Pega Medical have in the registry?
The registry currently lists 1 device for Orthopediatrics Canada Ulc Dba Pega Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthopediatrics Canada Ulc Dba Pega Medical's devices?
Among its 1 most recently registered device, Orthopediatrics Canada Ulc Dba Pega Medical has devices listed in FDA 510(k) (1 device).
What risk classes do Orthopediatrics Canada Ulc Dba Pega Medical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Orthopediatrics Canada Ulc Dba Pega Medical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthopediatrics Canada Ulc Dba Pega Medical?
FDA recall records list 1 recall initiated by Orthopediatrics Canada Ulc Dba Pega Medical, the most recent initiated on 4 Jul 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 Orthopediatrics Canada Ulc Dba Pega Medical in the registry?
The most recently registered devices listed for Orthopediatrics Canada Ulc Dba Pega Medical include Fassier-Duval Telescoping IM System.