PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 14, 2025 Initiated: April 10, 2025 #Z-1738-2025

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Tornier S.A.S.
Units Affected
438 users
Distribution
Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Location
Montbonnot-Saint-Martin, N/A

Frequently Asked Questions

What product was recalled?
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.. Recalled by Tornier S.A.S.. Units affected: 438 users.
Why was this product recalled?
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1738-2025.