Class II

Medical Device Recall: stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Tornier S.A.S. · March 5, 2025

Reason for Recall

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.

Distribution

US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

States Affected

AK, ID, MA, MN, PA, TN, TX

Quantity Affected

N/A

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1541-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Tornier S.A.S. Medical Device Recall: stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty | SafeCheck