Z-1738-2025 Class II Ongoing

Recalled by Tornier S.A.S. — Montbonnot-Saint-Martin, N/A

Recall Details

Product Type
Devices
Report Date
May 14, 2025
Initiation Date
April 10, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
438 users

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.

Distribution Pattern

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

Code Information

Software Version 4.2.1