Stryker Blueprint Mixed Reality Instrument Kit Recall for Total Shoulder Arthroplasty
Stryker is recalling the Blueprint Mixed Reality Instrument Kit for Total Shoulder Arthroplasty due to an elevated rate of complaints about software and instrumentation malfunctions that prevent the system from meeting its intended use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The source text does not report any illnesses, injuries, or adverse patient outcomes. The FDA has classified this as a Class II recall. The hazard is functional deficiency (software and instrumentation malfunction) rather than a direct health threat, and no injuries have been reported.
Plain-English summary
Stryker has identified an elevated complaint rate related to the Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN), used for Total Shoulder Arthroplasty procedures. The complaints indicate difficulties in using the system, with the most common issues involving impaired software functioning, impaired instrumentation functioning, and general product usability problems. These malfunctions prevent the system from meeting its intended use.
The affected product was distributed in the United States (Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho) as well as in France, Canada, and Ireland. Distribution occurred between August 23, 2023 and December 31, 2024. All lots manufactured through October 2024 are included in this recall.
Users of this device should contact Tornier S.A.S. or Stryker for information on how to address the reported issues or to inquire about replacement options.
The recalled product
- Product
- stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
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 x
Distribution
Part of a larger recall action
This product is one of 9 recalled by Tornier S.A.S. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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