Blue Ortho Recalls
3 recalls on record · February 19, 2020 to October 30, 2024 · Medical Devices
Recalls by year
20
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 30, 2024Medical DevicesFDA
Blue Ortho recalls Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua
Hazard: Predict+ is being recalled for lack of pre-market clearance/approval.
November 4, 2020Medical DevicesFDA
Blue Ortho recalls Instructions For Use document of the GPS Trackers.
Hazard: 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.
February 19, 2020Medical DevicesFDA
Blue Ortho recalls Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthrop
Hazard: The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).