[pending] Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder re
Pending LLM rewrite. Source: FDA_DEVICE Z-1738-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
The recalled product
- Product
- Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
- Manufacturer
- Tornier S.A.S.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version 4.2.1
Distribution
Distributed nationwide across the United States.
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