Stryker Blueprint Mixed Reality Surgical Instrument Kit Fails to Function Properly
Stryker is recalling the Blueprint Mixed Reality Instrument Kit for shoulder surgery due to elevated complaints of software and hardware failures that prevent proper use.
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 device that fails to meet its intended use, creating risk of harm during surgical procedures. No injuries or illnesses have been reported, placing it in the risk-of-harm category without documented harm.
Plain-English summary
Stryker is recalling the Blueprint Mixed Reality Instrument Kit (Catalog Number MRUEGLN), a surgical guidance system used in total shoulder replacement procedures. The company identified an elevated complaint rate indicating the system fails to meet its intended use due to multifactorial issues.
The most frequently reported problems involve impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. These failures prevent surgeons from using the system as designed for guidance during shoulder arthroplasty procedures.
The recalled instrument kits were manufactured through October 2024 and distributed from August 23, 2023, through December 31, 2024, to medical facilities in Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, Idaho, France, Canada, and Ireland. No injuries or illnesses have been reported to date.
Healthcare providers and facilities using this product should contact Stryker for instructions on replacement or service options. Patients who have undergone shoulder replacement surgery with this system should consult their surgeon if they have concerns about their procedure.
The recalled product
- Product
- stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-failure
- hardware-malfunction
- device-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 x
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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