Tornier recalls Blueprint Mixed Reality Glenoid Pin Guides (MRUE200) due to software and instrument failures affecting shoulder surgery. Affected units sold from Aug 2023 to Dec 2024.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Tornier is recalling Blueprint Mixed Reality Glenoid Pin Guides that have been reported to malfunction during shoulder surgery. These issues can prevent the device from working properly, which may lead to complications in surgical procedures.
The device has been reported to have software and hardware issues that prevent it from functioning correctly during shoulder surgery. These problems can cause the system to fail when it's needed for precise surgical guidance.
Surgical teams using the Tornier Blueprint Mixed Reality Glenoid Pin Guides for shoulder replacements are most at risk. Patients undergoing these procedures may face complications if the device fails during surgery.
Check for the catalog number MRUE200 on the product label. The device was sold in packages with catalog number MRUEGLN from August 2023 through December 2024.
Look for the catalog number MRUE200 on the device label to confirm it's affected.
The recall reports software and instrument issues that can prevent the device from working properly during surgery, but the risk level is low as it's reported to be a malfunction rather than a direct safety hazard.
Check for the catalog number MRUE200 on the device label. The product was sold in packages with catalog number MRUEGLN from August 2023 through December 2024.
The recall does not specify a remedy, so no action is required beyond checking if you have the product.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1534-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1534-2025 from Tornier. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
