PlainRecalls
FDA Devices Moderate Class II Ongoing

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Reported: April 16, 2025 Initiated: March 5, 2025 #Z-1535-2025

Product Description

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, 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.

Details

Recalling Firm
Tornier S.A.S.
Units Affected
22 units
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 Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty. Recalled by Tornier S.A.S.. Units affected: 22 units.
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-1535-2025.