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Tornier S.A.S. recalls stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Recalled April 16, 2025 · FDA recall Z-1542-2025 · Tornier S.A.S
Hazard
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. · FDA Class II
Units
14
Sold at
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Description
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.
Product
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Manufacturer(s)
Tornier S.A.S.
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →