Class II

Medical Device Recall: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Tornier S.A.S. · April 10, 2025

Reason for Recall

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

Distribution

Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.

States Affected

NATIONWIDE

Quantity Affected

438 users

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1738-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Tornier S.A.S. Medical Device Recall: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. | SafeCheck