FDA Recall: Software Bug Prevents User Access

Company: Tornier S.A.S.
Date of Enforcement Report: 5/8/2025
Class II

PRODUCT

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

Recall Number:

Z-1738-2025

REASON:

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

RECALLING FIRM/MANUFACTURER:

Tornier S.A.S.

VOLUME:

438 users

DISTRIBUTION:

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

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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