Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1541-2025 — stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

U.S. FDA — Device Enforcement · France · 2025-03-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1541-2025
Date of alert
2025-03-05
Country / jurisdiction
France
Risk level
Class II
Risk type
recall
Brand
Tornier S.A.S.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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