Z-1883-2024 Class II Ongoing
FDA device recall Z-1883-2024 was initiated by Tornier S.A.S. on April 16, 2024 and is designated Class II. 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 regu… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2024
- Initiation Date
- April 16, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Stryker Blueprint Software, Catalog #BPUE001.
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 Pattern
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Code Information
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.