Medical Device Recall: stryker HoloBlueprint Application, Catalog Number MRUE001; 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
14
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1542-2025
Status: ongoing
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