Blue Ortho
FranceFDA applicant, unverified
Part of Blue Ortho SAS
- Devices
- 6
- FDA recalls
- 31 ongoing
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
ExactechGPS® System Ref K213877
Regimes: 510(k) Registry: 510(k)ExactechGPS® System Ref K233299
Regimes: 510(k) Registry: 510(k)ExactechGPS Total Shoulder Application Ref K173372
Regimes: 510(k) Registry: 510(k)ExactechGPS System Ref K193618
Regimes: 510(k) Registry: 510(k)
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 1
- 2020 1
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 30 Aug 2024 Z-0209-2025 Class II Ongoing Predict+ is being recalled for lack of pre-market clearance/approval.
2020
- 10 Sep 2020 Z-0288-2021 Class II Terminated Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.
2019
- 22 Sep 2019 Z-1149-2020 Class II Terminated The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
Frequently asked questions
How many devices does Blue Ortho have in the registry?
The registry currently lists 6 devices for Blue Ortho. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Ortho's devices?
Among its 6 most recently registered devices, Blue Ortho has devices listed in FDA 510(k) (6 devices).
What risk classes do Blue Ortho's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Blue Ortho's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Blue Ortho?
FDA recall records list 3 recalls initiated by Blue Ortho, the most recent initiated on 2024-08-30. 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 Blue Ortho in the registry?
The most recently registered devices listed for Blue Ortho include ExactechGPS Total Shoulder Application, Equinoxe Planning Software, ExactechGPS® System, ExactechGPS Total Shoulder Application and ExactechGPS System.