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Open, Classified

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

FDA Recall Z-1738-2025 · Posted 2025-05-08

Recalling FirmTornier S.A.S.
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2025-04-10
Product Quantity438 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.

Firm Action

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.

Root Cause

Software Design Change

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211359Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationTornier, Inc. · 2021-11-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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