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

FDA Recall #Z-1738-2025 — Class II — April 10, 2025

Recall #Z-1738-2025 Date: April 10, 2025 Classification: Class II Status: Ongoing

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.

Recalling Firm

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

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

438 users

Distribution

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

Code Information

Software Version 4.2.1

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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