Gieres, France
Blue Ortho recalls
3 recalls recorded since 2018, most recently on 30 August 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 30 August 2024
- Reason
- Predict+ is being recalled for lack of pre-market clearance/approval.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0209-2025
- Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Terminated Class II Medical devices
- Recall started
- 10 September 2020
- Terminated
- 31 May 2023
- Reason
- 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.
- Distribution
- Domestic Distribution Only: CA, CO, SC and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0288-2021
- Instructions For Use document of the GPS Trackers.
Terminated Class II Medical devices
- Recall started
- 22 September 2019
- Terminated
- 23 July 2020
- Reason
- The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
- Distribution
- AZ, CA, FL, TN Foreign: Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1149-2020
- Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.