Medical device recalls Moderate risk

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

Recall date
April 10, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1738-2025
FDA classification
Class II
Brand / firm
Tornier S.A.S.
Sold / distributed
Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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