Recall Z-0209-2025— Blue Ortho

Name: FDA recall Z-0209-2025
Creator: U.S. Food and Drug Administration
Published: 2024-08-30

Class II · Ongoing

Class II FDA medical device recall by Blue Ortho, initiated 2024-08-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery. Reason: Predict+ is being recalled for lack of pre-market clearance/approval..

Recalling firm: Blue Ortho
Classification: Class II
Status: Ongoing
Initiated: 2024-08-30
Firm location: Meylan, N/A, France

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.