FDA Enforcement
Class II
Ongoing
Stryker Blueprint Software, Catalog #BPUE001.
Recall: Z-1883-2024
·
Reported May 29, 2024
Enforcement
- Recall Number
- Z-1883-2024
- Event ID
- 94444
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Tornier S.A.S.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 29, 2024
- Initiation Date
- April 16, 2024
- Classification Date
- May 22, 2024
- Address
- 161 Rue Lavoisier, Montbonnot St Martin, N/A, France
Description
Stryker Blueprint Software, Catalog #BPUE001.
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.
Code Info
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
Distribution
US Nationwide distribution in the states of FL, KY, NJ, and WI.