stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Reported: April 16, 2025 Initiated: March 5, 2025 #Z-1541-2025
Product Description
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.
Details
- Recalling Firm
- Tornier S.A.S.
- Units Affected
- N/A
- Distribution
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Location
- Montbonnot-Saint-Martin, N/A
Frequently Asked Questions
What product was recalled? ▼
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recalled by Tornier S.A.S.. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 16, 2025. Severity: Moderate. Recall number: Z-1541-2025.
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