FDA-Device2024-05-29Class II
Stryker Blueprint Software, Catalog #BPUE001.
Tornier S.A.S.
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Manufactured in
161 Rue Lavoisier, Montbonnot St Martin, France
Products
Stryker Blueprint Software, Catalog #BPUE001.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2024Don't want to check this manually?
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