Tornier S.A.S. recalls Blueprint Software

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

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

On April 10, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed that an Online Management System (OMS) software patch was released to address the bug on March 25, 2025. The issue can no longer occur with the introduction of this patch. No actions are required on the customer's part to implement the patch. Version 4.2.2 is currently in development and is scheduled for release by end of Quarter 2, 2025. This patch will implement a permanent fix for the issue. Customers will be prompted to complete this update within the Blueprint Software when it is available.

• FDA enforcement recordOfficial FDA database entry for Z-1738-2025
• FDA 510(k) clearance · K211359The device's official FDA premarket clearance record
• FDA device classification · PHXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tornier S.A.S.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.