Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individua
Summary
The FDA issued a Class II for Predict+ is a data-driven, clinical decision support tool that uses machine lear by Blue Ortho. Reason: Predict+ is being recalled for lack of pre-market clearance/approval..
Details
Source
Device Recall
External ID
Z-0209-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
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
Lot/Code Info: Software version v1.3
Quantity Affected: 136 software units
Reason for Recall
Predict+ is being recalled for lack of pre-market clearance/approval.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-08-30
Company
Meylan, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Blue Ortho has 5 FDA actions in our database, including 1 recall and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blue Ortho) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blue Ortho have FDA actions?
Blue Ortho has 5 FDA actions in our database, including 1 recall and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0209-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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