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TRUVACE RECORD VERSION
record: TRV-2026-0044
version: 3
kind: revised
reason: Model backfill: grounded claim, summary, sector, and trace validation
timestamp: 2026-07-13T00:40:22.763387Z
status: published
lens: trace
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: Predict+ uses machine learning to provide individualized outcome predictions after shoulder replacement surgery to support clinical decision making.
problem_title: Predict+ was recalled and withdrawn from the US market because it lacked required pre-market clearance/approval.
trace_subject: Predict+ machine learning predictions for patients after shoulder replacement surgery
gain_reading: Predict+ uses machine learning to provide individualized outcome predictions after shoulder replacement surgery to support clinical decision making.
problem_reading: Predict+ was recalled and withdrawn from the US market because it lacked required pre-market clearance/approval.
quick_read: Blue Ortho recalled its Predict+ software, a data-driven clinical decision support tool that uses machine learning to predict individual outcomes after shoulder replacement surgery. The recall reason was lack of pre-market clearance/approval, and the company issued a DHCP notice to active users on 08/30/2024 via email stating the software is being withdrawn from the US market until approval is achieved.

The case matters because it shows regulatory enforcement catching AI-enabled decision support tools that reached users without clearance, removing a predictive aid from clinical use. It remains unclear how long approval will take, whether the tool was used to influence surgical decisions before withdrawal, and what validation will be required for return to market.
limitation: Article does not report patient harm, number of users affected, or timeline for obtaining clearance.
tag: Model-validated trace
key_points: Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email about the withdrawal. | The company stated the software is being withdrawn from the US market until applicable pre-market approval is achieved. | The notice stated there are no actions users need to take beyond confirming receipt of the email.
rundown: Blue Ortho recalled its Predict+ software, a data-driven clinical decision support tool that uses machine learning to predict individual outcomes after shoulder replacement surgery. The recall reason was lack of pre-market clearance/approval, and the company issued a DHCP notice to active users on 08/30/2024 via email stating the software is being withdrawn from the US market until approval is achieved.

The case matters because it shows regulatory enforcement catching AI-enabled decision support tools that reached users without clearance, removing a predictive aid from clinical use. It remains unclear how long approval will take, whether the tool was used to influence surgical decisions before withdrawal, and what validation will be required for return to market.
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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