FDA Medical Device Recalls (openFDA)
Blue Ortho: 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 number
- Z-0209-2025
- 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
- Status
- Open, Classified
- Initiated
- 2024-08-30
- Posted
- 2024-10-24
- Terminated
- not on file
- Reason
- Predict+ is being recalled for lack of pre-market clearance/approval.
- 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 The email informed users the software is being withdrawn from the US market until applicable pre-market approval is achieved.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
- 136 software units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Software version v1.3
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3008027912
- Firm city
- Meylan
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28