Stryker Blueprint Mixed Reality surgical guidance system Class II recall
Stryker is recalling the Blueprint Mixed Reality Box Base used in Total Shoulder Arthroplasty due to elevated complaints of software and instrumentation malfunctions that prevent intended use.
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 with no reported illnesses or injuries. The hazard involves system malfunction that prevents intended use but does not present a direct safety threat, making it a moderate-severity voluntary recall.
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Box Base (Catalog Number MRUE204), packaged in the Stryker Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN), used for Total Shoulder Arthroplasty guidance. The recall affects 51 units distributed in the United States (Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho) as well as France, Canada, and Ireland between August 23, 2023, and December 31, 2024. All lots manufactured through October 2024 are included.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. The company determined the issues are multifactorial but in each instance prevent the system from meeting its intended use. The most commonly reported complaints involved impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Patients or healthcare providers with questions about this recall should contact the recalling firm, Tornier S.A.S., or Stryker for further guidance.
The recalled product
- Product
- stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-malfunction
- device-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 03700434022964
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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