FDA-Device2025-04-16Class II
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
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.
Sold states
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Affected count
51 units
Manufactured in
161 Rue Lavoisier, N/A, Montbonnot-Saint-Martin, N/A, France
Products
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2025Don't want to check this manually?
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