Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Summary
The FDA issued a Class II for Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical pla by Tornier S.A.S.. Reason: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software..
Details
Source
Device Recall
External ID
Z-1738-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Lot/Code Info: Software Version 4.2.1
Quantity Affected: 438 users
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-10
Company
Montbonnot-Saint-Martin, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Tornier S.A.S.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Tornier S.A.S. have FDA actions?
Tornier S.A.S. has 15 FDA actions in our database, including 13 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1738-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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