Stryker Blueprint Coracoid Clamp Guidance System Software and Instrumentation Failures
Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to complaints of impaired software and instrumentation functioning that prevent the system from working as intended. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical guidance system with no reported illnesses or injuries. However, the device malfunction prevents it from meeting its intended use in a surgical context, qualifying as a risk-of-harm product. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp (Catalog Number MRUE202), packaged in the Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN). This device provides guidance during total shoulder replacement surgery.
The company received multiple complaints about difficulties using the guidance system. The most common issues reported were impaired software functioning and impaired instrumentation functioning. These malfunctions prevent the device from performing its intended function during surgery.
The recalled devices were distributed to healthcare facilities in Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho, as well as in France, Canada, and Ireland. Twenty units were involved in this recall.
Healthcare facilities using or possessing this device should contact their Stryker representative for remediation guidance. Providers should assess whether they have experienced similar issues and report any complications to Stryker and the FDA.
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
- device-malfunction
- software-failure
- instrumentation-failure
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
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03