Tornier recalls Blueprint Mixed Reality Depth Stop Pin (MRUE206) for software and instrumentation problems affecting shoulder surgery. All units made through Oct 2024 are affected.
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 Depth Stop Pin (MRUE206) for total shoulder arthroplasty procedures due to reported issues with software and hardware functionality. This could prevent the system from working as intended during surgery.
The device has been reported to malfunction with software and hardware components, which can prevent it from functioning properly during surgery. This may lead to difficulties in the surgical procedure but does not indicate immediate danger to patients.
Surgeons and medical staff using the Blueprint Mixed Reality Depth Stop Pin for shoulder surgeries are affected. Patients undergoing total shoulder arthroplasty procedures are at risk if the device fails during surgery.
Check for the catalog number MRUE206 on the device. The product was distributed from August 23, 2023, through December 31, 2024. All units made through October 2024 are included in this recall.
Look for the catalog number MRUE206 on the device to confirm it is part of this recall.
The recall is due to reported software and instrumentation issues that may prevent the device from working as intended during surgery, but it does not indicate immediate danger to patients.
Check for the catalog number MRUE206 on the device. The product was distributed from August 23, 2023, through December 31, 2024, and all units made through October 2024 are affected.
The recall does not specify a remedy, so you should contact 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-1540-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1540-2025 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.
