RecallDepth

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

Company
Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France
Recall Initiated
April 10, 2025
Posted
May 8, 2025
Recall Number
Z-1738-2025
Quantity
438 users

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.

Lot / Code Info

Software Version 4.2.1

Root Cause

Software Design Change

Action Taken

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.

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