Blue Ortho

3 recalls •

🏥 Medical Devices

• Categories: Infusion Pumps, Other Medical Devices, Implants & Prosthetics

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

Class I - Dangerous

Predict+ is being recalled for lack of pre-market clearance/approval.

Aug 30, 2024 Infusion Pumps Nationwide View Details →

Instructions For Use document of the GPS Trackers.

Class I - Dangerous

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.

Sep 10, 2020 Other Medical Devices View Details →

Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

Class I - Dangerous

The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).

Sep 22, 2019 Implants & Prosthetics View Details →