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TRUVACE RECORD VERSION
record: TRV-2026-0044
version: 4
kind: revised
reason: Model backfill: grounded claim, summary, sector, and trace validation
timestamp: 2026-07-13T05:15:47.773562Z
status: published
lens: p_space
sector: health
headline: Blue Ortho 22 Chemin Du Vieux Chene Meylan France recalls an AI-enabled medical device
dek: Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery Recall reason: Predict+ is being recalled for lack of pre-market clearance/approval.
gain_title: (none)
problem_title: Predict+ was recalled because the AI-enabled clinical decision support tool for shoulder replacement outcomes lacked required pre-market clearance/approval.
trace_subject: (none)
gain_reading: (none)
gain_evidence: (none)
problem_reading: Predict+ was recalled because the AI-enabled clinical decision support tool for shoulder replacement outcomes lacked required pre-market clearance/approval.
problem_evidence: Predict+ is being recalled for lack of pre-market clearance/approval. | uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
quick_read: On 2026-02-05, Blue Ortho initiated a recall of Predict+, an AI-enabled clinical decision support tool that uses machine learning to predict outcomes after shoulder replacement surgery, because the device lacked pre-market clearance/approval.

The case illustrates a concrete regulatory consequence for deploying an AI clinical tool without authorization, highlighting gaps in pre-market oversight for machine learning decision support. What is still unknown is the scale of deployment, any clinical impact, and the pathway to compliance.
limitation: Article text provides only recall reason and device purpose; no details on patient harm, distribution volume, or regulatory action timeline.
tag: Evidence-backed problem
key_points: Predict+ is described as a data-driven clinical decision support tool that uses machine learning for shoulder replacement outcomes. | The recall reason listed is lack of pre-market clearance/approval. | Manufacturer identified as Blue Ortho at 22 Chemin Du Vieux Chene Meylan France.
rundown: By 2026-02-05, npj Digital Medicine reported that Blue Ortho recalled Predict+, a data-driven clinical decision support tool that uses machine learning to predict individual patient outcomes after shoulder replacement surgery. The stated recall reason was lack of pre-market clearance/approval.

The recall matters because it shows regulatory enforcement catching an AI-enabled surgical planning tool deployed without required authorization, raising questions about how many patients were exposed and whether efficacy claims were validated. It remains unclear whether the recall involved safety issues, patient harm, or only procedural non-compliance.
sources:
- peer_reviewed | npj Digital Medicine | https://doi.org/10.1038/s41746-026-02353-7 | 2026-02-05
- government | FDA medical-device recall 209984 | https://api.fda.gov/device/recall.json?search=cfres_id%3A%22209984%22&sort=event_date_created%3Adesc&limit=1 | 2024-08-30
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