FDA recall Z-1738-2025

Tornier S.A.S. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2025-04-10
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Montbonnot-Saint-Martin, N/A, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1738-2025