Tornier S.A.S. recalls stryker HoloBlueprint Application, Catalog Number MRUE001; T
Recalled Product
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Hazard / Issue
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.
Issued by
FDA
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