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Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.
Recalled May 29, 2024 · FDA recall Z-1883-2024 · 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. · FDA Class II
Sold at
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Description
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.
Product
Stryker Blueprint Software, Catalog #BPUE001.
Manufacturer(s)
Tornier S.A.S.
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →