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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Blueprint Shoulder Planning Software Recalled for Data Access Bug

Agency Publication Date: May 8, 2025
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Summary

Tornier S.A.S. has recalled Blueprint Software version 4.2.1, which is used by surgeons as a pre-surgical planner for shoulder replacement. The recall affects 438 users nationwide. A software bug in this specific version prevents users from accessing surgical cases that were initiated in older versions of the software. No injuries have been reported at this time.

Risk

A software bug prevents surgeons from opening existing patient cases and surgical plans. This can lead to surgical delays or the loss of clinical planning data required for shoulder replacement procedures.

What You Should Do

  1. This recall affects Blueprint Software version 4.2.1 (catalog number BPUE001), which is used by surgeons for pre-surgical shoulder replacement planning.
  2. Identify whether your facility is currently running Blueprint Software version 4.2.1.
  3. Stop using the recalled software version and avoid attempting to access previous cases through this version until it is updated.
  4. Contact Tornier S.A.S. or your authorized medical distributor to arrange for a software correction or update.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) if you have additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Blueprint Software
Variants: Software Version 4.2.1
Model / REF:
BPUE001

Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96651
Status: Active
Manufacturer: Tornier S.A.S.
Sold By: Authorized medical distributors
Manufactured In: France
Units Affected: 438 users
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.