Stryker Blueprint Mixed Reality Glenoid Digitizer Software Functioning Issues
Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer due to elevated complaint rates affecting system functionality. The device cannot reliably meet its intended use in total shoulder arthroplasty procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text explicitly states no illnesses or injuries reported; the hazard is functional failure during surgical guidance. Without reported adverse clinical outcomes, and given that the issue is impaired functioning rather than a structural defect or known pathogen, the recall meets the criteria for Moderate severity.
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer (Catalog Number MRUE201), packaged in the Stryker Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN), used in total shoulder arthroplasty procedures. The recall affects 22 units distributed to hospitals and surgical centers in Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho, as well as in France, Canada, and Ireland between August 23, 2023, and December 31, 2024.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. These issues prohibit the system from meeting its intended use in surgical guidance.
Healthcare facilities that received this device should stop using the affected units and contact Stryker for guidance on replacement or further instructions. Patients who have had surgery using this device should consult their healthcare provider if they have concerns about their procedure.
The recalled product
- Product
- stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-malfunction
- impaired-functionality
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots manufactured through Oct 2024
- Distributed 23-Aug-2023 through 31-Dec-2024
- GTIN 03700434022933
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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