FDA recall Z-0209-2025

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

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-08-30

Report date

2024-10-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Meylan, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0209-2025