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Recall Observatory FDA recall evidence

Device product

stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Z-1541-2025

March 05, 2025

Class II

Product summary

Firm
Tornier S.A.S.
Event
Event 96437
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1541-2025

Official wording

Reason: 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.

Code information: All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN x

Distribution pattern: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.