Class II

Medical Device Recall: Stryker Blueprint Software, Catalog #BPUE001.

Tornier S.A.S. · April 16, 2024

Reason for Recall

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.

Distribution

US Nationwide distribution in the states of FL, KY, NJ, and WI.

States Affected

NATIONWIDE

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1883-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.