Tornier S.A.S.: Device Recall

Recall #Z-1883-2024 · 04/16/2024

Class II: Risk

Recall Details

Recall Number: Z-1883-2024
Classification: Class II
Product Type: Device
Recalling Firm: Tornier S.A.S.
Status: Ongoing
Date Initiated: 04/16/2024
Location: Montbonnot St Martin, France
Voluntary/Mandated: Voluntary: Firm initiated

Reason for Recall

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

Product Description

Stryker Blueprint Software, Catalog #BPUE001.

Distribution Pattern

US Nationwide distribution in the states of FL, KY, NJ, and WI.

Other Recalls by Tornier S.A.S.

Class II: Risk 04/10/2025

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