Stryker Blueprint Mixed Reality Depth Stop Pin Total Shoulder Arthroplasty Recalled
Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaints of software and instrumentation malfunctions that prevent intended use. The recall affects 474 units distributed in multiple US states and internationally.
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 does not report any actual injuries, illnesses, or hospitalizations—only operational difficulties and functional impairment. With no reported harm, the severity is moderate per the rubric.
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206, used in Total Shoulder Arthroplasty procedures. The manufacturer identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system.
The reported issues are multifactorial but consistently prevent 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.
A total of 474 units were affected. The devices were distributed from August 23, 2023 through December 31, 2024 to locations in Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho, as well as to France, Canada, and Ireland.
Patients and healthcare providers should contact Stryker directly regarding this recall for instructions on managing affected devices.
The recalled product
- Product
- stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-malfunction
- device-malfunction
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 03700434022988
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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