Home / Recalls / Blue Ortho / Z-0209-2025

Z-0209-2025 Class II Ongoing

Recalled by Blue Ortho — Meylan, N/A

FDA device recall Z-0209-2025 was initiated by Blue Ortho on Aug 30, 2024 and is designated Class II. Reason for recall: Predict+ is being recalled for lack of pre-market clearance/approval. The recall status is ongoing. Affected quantity: 136 software units.

Recall details

Product Type: Devices
Report Date: Oct 30, 2024
Initiation Date: Aug 30, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 136 software units

Product description

Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery

Reason for recall

Predict+ is being recalled for lack of pre-market clearance/approval.

Distribution pattern

US Nationwide distribution.

Code information

Software version v1.3

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0209-2025
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.