Recall Z-1738-2025
Tornier S.A.S. · initiated April 10, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Codes / lots: Software Version 4.2.1
Reason for recall
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
FDA-determined 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.
Details
- Recall number
- Z-1738-2025
- Initiated
- April 10, 2025
- Posted by FDA
- May 8, 2025
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 438 users
- Distribution
- Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
- Recalling firm
- Tornier S.A.S., Montbonnot-Saint-Martin