Device product
Stryker Blueprint Software, Catalog #BPUE001.
Z-1883-2024
Product summary
- Firm
- Tornier S.A.S.
- Event
- Event 94444
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
device-enforcement:Z-1883-2024
Official wording
Reason: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
Code information: Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Distribution pattern: US Nationwide distribution in the states of FL, KY, NJ, and WI.
Derived failure modes
-
Device software or design
software bug