Company: Tornier S.A.S.
Date of Enforcement Report: 5/22/2024
Class II
PRODUCT
Stryker Blueprint Software, Catalog #BPUE001
Recall Number:
Z-1883-2024
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.
RECALLING FIRM/MANUFACTURER:
Tornier S.A.S.
DISTRIBUTION:
US Nationwide distribution in the states of FL, KY, NJ, and W
