Stryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Glenoid Pin Guide due to elevated complaint rates regarding software and instrumentation functioning issues that prevent the product 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 affecting a medical device. The source text indicates functional impairment and difficulties using the product but explicitly states no injuries or illnesses have been reported, making this a precautionary recall for a device malfunction without documented harm.
Plain-English summary
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide (Catalog Number MRUE200), distributed in the Stryker Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN) for use in Total Shoulder Arthroplasty procedures. The recall affects 3 units distributed in the United States, France, Canada, and Ireland from August 23, 2023 through 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 include impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. In each instance, these issues prohibit the system from meeting its intended use.
Physicians and hospitals using this product should contact their Stryker representative or the company directly for instructions regarding this recall. All units manufactured through October 2024 are included in this recall.
The recalled product
- Product
- stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Affected units
- 3
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 03700434022926
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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