Z-0209-2025Class II

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions...

Name: Z-0209-2025 Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions...
Creator: Blue Ortho
Published: 2024-08-30
License: https://open.fda.gov/license/

Blue Ortho / initiated 2024-08-30 / Open, Classified

FDA source

Blue Ortho began a recall of Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder... on 2024-08-30. FDA classified it as Class II and gives the reason as "Predict+ is being recalled for lack of pre-market clearance/approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0209-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-10-24
Recalling firm: Blue Ortho
Product: Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery
Product code: N/A
Reason for recall: Predict+ is being recalled for lack of pre-market clearance/approval.
FDA root cause: No Marketing Application
Action: Blue Ortho issued a DHCP notice to its active users on 08/30/2024 via email. The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved. There are no actions users need to take. Blue Ortho requested users confirm receipt of the email.
Quantity in commerce: 136 software units
Distribution: US Nationwide distribution.
Product codes and lots: Software version v1.3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0209-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0209-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)