Day

May 22, 2024
22
May

FDA Recall: Software Bug Allows for Configurations Incompatible or Not Approved

May 22, 2024
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....
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