Predict+ Tool (Blue Ortho) – Pre-Market Clearance Problem (2024)
Software lacking pre-market approval may pose potential regulatory compliance issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Blue Ortho 22 Chemin Du Vieux Chene Meylan France
Lot Codes / Batch Numbers
Software version v1.3
Products Sold
Software version v1.3
Blue Ortho 22 Chemin Du Vieux Chene Meylan France is recalling Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide pred due to Predict+ is being recalled for lack of pre-market clearance/approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Predict+ is being recalled for lack of pre-market clearance/approval.
Recommended Action
Per FDA guidance
Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email. The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved. There are no actions users need to take. Blue Ortho requested users confirm receipt of the email.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026