stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1541-2025