FDAFDA · Food and drugs·Recall number Z-1541-2025
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Published April 16, 2025 · Recall initiated: March 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Tornier S.A.S.
- Distributor
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Lot
- All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN x
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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