Stryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues
Stryker is recalling the Blueprint Mixed Reality Glenoid Box Lid and related instrumentation kits due to elevated complaint rates. The product experiences software and instrumentation issues that prevent it 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: This is an FDA Class II recall. The source text indicates complaints of functionality issues that prevent intended use but does not report any hospitalizations, injuries, or adverse health consequences. This aligns with a moderate-severity classification for a device malfunction recall without reported patient harm.
Plain-English summary
Stryker has issued a recall of the Blueprint Mixed Reality Glenoid Box Lid (Catalog Number MRUE205), packaged in the Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN), used in Total Shoulder Arthroplasty procedures. Approximately 51 units were distributed from August 23, 2023 through December 31, 2024, across multiple states and countries including Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, Idaho, France, Canada, and Ireland.
The recall was initiated due to an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. The complaints identified include impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. These issues prohibit the system from meeting its intended use.
Affected units were manufactured through October 2024 and carry GTIN 03700434022971. Healthcare facilities and providers who received this product should contact Tornier S.A.S. directly for instructions on remediation or replacement.
The recalled product
- Product
- stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Affected units
- 51
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 03700434022971
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.
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