Z-1539-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- March 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51 units
Product Description
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reason for Recall
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.
Distribution Pattern
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Code Information
All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022971