UnratedMedical device recall · FDA · Published August 30, 2024
Blue Orth: Predict+ Software Lacks Pre-Market Approval
Blue Ortho recalls Predict+ software for shoulder surgery decision support due to lack of pre-market clearance. Users should check software version v1.3 for affected units.
“Blue Orth: Predict+ Software Lacks Pre-Market Approval.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54145-blue-orth-predict-software-lacks-pre-market-approval. Based on FDA recall #Z-0209-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2025%22&limit=1).
The FDA announced on Aug. 30, 2024, that Blue Ortho is voluntarily recalling its Predict+ clinical decision support tool for lack of pre-market clearance. The recall affects 136 software units distributed nationwide.
How to tell if you have it
Brand: Blue Ortho
Product: Predict+
Software version: v1.3
Units affected: 136
The hazard
Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery. The recall is due to the product lacking pre-market clearance or approval.
Context
GovInfoNow's records show Blue Ortho has two other recalls on record since Sept. 22, 2019. Other recent recalls of similar products include Blue Ortho GPS Trackers (Sept. 10, 2020) and Blue Ortho TKA Pro v2.1 Software (Sept. 22, 2019). Other recent recalls of similar products include Siemens SOMATOM X.ceed Software Applications (Dec. 19, 2025).
How to tell if you have this one
Check if you have Predict+ software version v1.3 used for shoulder replacement surgery predictions. The software is sold by Blue Ortho for clinical decision support.
Brand
Blue Ortho
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Identify if your Predict+ software is version v1.3 used for shoulder replacement surgery predictions.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0209-2025 (August 30, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0209-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.