Device product
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Z-1536-2025
Product summary
- Firm
- Tornier S.A.S.
- Event
- Event 96437
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1536-2025
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 03700434022940
Distribution pattern: US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Derived failure modes
-
Unknown
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.