Tornier recalls Blueprint Mixed Reality Box Base (MRUE204) 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 Box Base (catalog number MRUE204) because users report software and hardware issues that prevent the device from working properly during shoulder surgery. This could lead to difficulties in the surgical process if the device doesn't function as intended.
The device has been reported to have software and hardware issues that prevent it from meeting its intended use in shoulder surgery. These problems can cause difficulties in the surgical process, but the recall does not specify a risk of serious injury.
Surgical teams using the Blueprint Mixed Reality Box Base for total shoulder arthroplasty procedures are affected. Patients undergoing shoulder surgery with this device may be at risk if the system doesn't function correctly.
Check for the catalog number MRUE204 on the Blueprint Mixed Reality Box Base. The product was sold from August 2023 through December 2024, packaged with the Blueprint Mixed Reality Instrument Kit (catalog number MRUEGLN).
Look for the catalog number MRUE204 on the Blueprint Mixed Reality Box Base.
Tornier identified an elevated complaint rate related to software and instrumentation issues that prevent the device from meeting its intended use during shoulder surgery.
The recall does not specify a remedy, so check the product details to see if it matches the catalog number MRUE204.
The recall does not mention a risk of serious injury; it focuses on difficulties using the device.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1538-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1538-2025 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.
