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.
Predict+ is being recalled for lack of pre-market clearance/approval.
Blue Ortho is recalling its Predict+ software, which uses machine learning to predict shoulder replacement outcomes. The software lacks required pre-market approval from regulators, making it unsafe for clinical use.
Predict+ software was not approved by regulatory authorities before being used in clinical settings. This lack of pre-market clearance means it may not meet safety standards for medical devices.
Healthcare providers using Predict+ software for shoulder surgery decisions are likely affected. Patients receiving shoulder replacements through this tool face the highest risk.
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.
Identify if your Predict+ software is version v1.3 used for shoulder replacement surgery predictions.
The recall states Predict+ lacks pre-market approval, so it is not approved for clinical use. Users should stop using it until a remedy is provided.
The recall does not specify a remedy, so users should check software version and contact Blue Ortho for guidance.
The recall indicates it lacks regulatory approval, which could pose safety risks, but the exact hazard is not detailed in the record.
We’ve drafted a message you can send Blue Ortho to request your refund or repair — edit it as you like.
Subject: Recall Z-0209-2025 — Blue Ortho Blue Ortho Hello, I own a Blue Ortho that is covered by recall Z-0209-2025 from Blue Ortho. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
