Tornier S.A.S.: Device Recall

Recall #Z-1738-2025 · 04/10/2025

Class II: Risk

Recall Details

Recall Number: Z-1738-2025
Classification: Class II
Product Type: Device
Recalling Firm: Tornier S.A.S.
Status: Ongoing
Date Initiated: 04/10/2025
Location: Montbonnot-Saint-Martin, N/A, France
Voluntary/Mandated: Voluntary: Firm initiated
Product 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.

Product Description

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

Distribution Pattern

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

Other Recalls by Tornier S.A.S.

Class II: Risk 03/05/2025

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Class II: Risk 03/05/2025

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Class II: Risk 03/05/2025

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Class II: Risk 03/05/2025

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Class II: Risk 03/05/2025

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

View all recalls by Tornier S.A.S. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.