From Health 201AI Med Risk

What happenedOn August 30, 2024, Blue Ortho emailed active US users that it was withdrawing Predict+ from the US market until it had regulatory approval. Predict+ is a machine-learning clinical decision support tool, marketed with Exactech's shoulder arthroplasty planning software. It predicts individual patient outcomes after shoulder replacement surgery. The FDA classified the action as a Class 2 recall (Z-0209-2025) 'for lack of pre-market clearance/approval', covering 136 software units distributed nationwide. No patient harm or specific prediction error was reported. In April 2025 Exactech released a new version of Predict+ in Europe and Australia and stated that it 'has not received FDA marketing authorization'.

Failure modeMachine-learning outcome predictions used to inform surgical planning were distributed to US surgeons before any regulatory review of the model's validation. Clinicians had no independent assurance that the predictions were accurate for their patients.

What might have helpedTreating the regulatory status of predictive models embedded in surgical planning software as a prerequisite for patient use could have prevented unauthorized deployment. Disabling machine learning prediction features in jurisdictions where they lack authorization might have mitigated compliance risks. Requiring documented external validation on comparable populations before surgeons incorporate these predictions into consent or planning discussions could have ensured greater reliability.