Blue Ortho: Medical Device Recall in 2024 - (Recall #: Z-0209-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: August 30, 2024

Date Posted: October 30, 2024

Recall Number: Z-0209-2025

Event ID: 95322

Reason for Recall:

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

Status: Ongoing

Product Quantity: 136 software units

Code Information:

Software version v1.3

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated