Blueprint Software version 4.2.1 surgical planner access bug
Tornier's Blueprint Software version 4.2.1 contains a bug that prevents surgeons from accessing surgical cases created in earlier software versions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a software functionality issue (inability to access prior case data) that creates operational disruption rather than direct patient harm. No actual adverse health consequences are documented.
Plain-English summary
Tornier S.A.S. is recalling Blueprint Software version 4.2.1, a surgical planning tool used by surgeons to prepare for shoulder replacement procedures. The software contains a bug that prevents users from accessing cases initiated in previous versions of the software.
Approximately 438 users of Blueprint Software are affected by this issue. The software is distributed nationwide in the United States.
Users experiencing problems accessing cases from previous software versions should contact Tornier S.A.S. for technical support and assistance.
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.
- Affected units
- 438
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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