FDAClass IIMay 14, 2025

Blueprint Software recall: Software Issue

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

Why was Blueprint Software recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software Version 4.2.1

Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Recalling firm
Tornier S.A.S.
Quantity
438 users
Distribution
Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Recall date
May 14, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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