FDA recall Z-1883-2024

Product

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

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

Key facts

Status

Ongoing

Initiation date

2024-04-16

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Montbonnot St Martin, France

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1883-2024