Tornier recalls Blueprint Mixed Reality Glenoid Digitizers (MRUE201) due to software and instrumentation problems affecting shoulder surgery. Affected units were sold from August 2023 to December 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 its Blueprint Mixed Reality Glenoid Digitizer (MRUE201) because users report software and hardware issues that prevent the device from working properly during shoulder surgery. This could lead to errors in surgical procedures if the device fails to function as intended.
The device has reported software and hardware problems that prevent it from functioning correctly during shoulder surgery. These issues could lead to errors in surgical planning or execution if the device doesn't work as intended.
Surgical teams using the Tornier Blueprint Mixed Reality Glenoid Digitizer for shoulder replacements are most at risk. Patients undergoing these procedures may be affected if the device fails during surgery.
Check for the catalog number MRUE201 on the device or packaging. The product was sold from August 2023 through December 2024 for shoulder replacements.
Verify if your device has the catalog number MRUE201 and was sold between August 2023 and December 2024.
The recall is due to reported software and hardware issues that prevent the device from working properly during shoulder surgery, but no specific injuries have been reported.
Check for the catalog number MRUE201 on the device or packaging. The product was sold from August 2023 through December 2024.
The recall does not include a specific remedy, so you should check with Tornier directly for guidance.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1535-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1535-2025 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.
