Device product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Z-1738-2025
Product summary
- Firm
- Tornier S.A.S.
- Event
- Event 96651
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 438 users
- Official record key
device-enforcement:Z-1738-2025
Official wording
Reason: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Code information: Software Version 4.2.1
Distribution pattern: Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Derived failure modes
-
Device software or design
software bug