Stryker Blueprint Mixed Reality Coracoid Clamp Software and Instrumentation Issues
Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to elevated complaints about impaired software and instrumentation functioning that prevent the system from meeting its intended use in shoulder surgery guidance.
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 involving a medical device with no reported illnesses, injuries, or deaths. The hazard is functional failure that prevents intended use, which is addressed as a precautionary measure and does not meet the thresholds for High or above per the rubric.
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in the stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN. The device is used to provide guidance during total shoulder arthroplasty procedures.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. The most commonly reported complaints involved impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. In each instance, these issues prevented the system from meeting its intended use.
The affected product was distributed in the United States and internationally between August 23, 2023, and December 31, 2024. A total of 20 units were distributed across multiple states and countries. All lots manufactured through October 2024 are subject to this recall.
Healthcare providers and facilities that received this product should contact Tornier S.A.S. for guidance on remedial actions. Patients who may have undergone procedures using this device should consult their healthcare provider if they have concerns about their surgical outcome.
The recalled product
- Product
- stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, 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 03700434022940
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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