FDA-Device2025-05-14Class II
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Tornier S.A.S.
Hazard
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Sold states
Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Affected count
438 users
Manufactured in
161 Rue Lavoisier, N/A, Montbonnot-Saint-Martin, N/A, France
Products
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1738-2025Don't want to check this manually?
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