Tornier recalls Blueprint Mixed Reality Coracoid Clamps (MRUE202) 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 Coracoid Clamps (catalog number MRUE202) because users report software and hardware issues that prevent the device from working properly during shoulder surgery. This could lead to complications in surgical procedures if the device fails to function as intended.
The device has reported software and hardware issues that prevent it from functioning correctly during shoulder surgery. These problems can cause the system to fail in meeting its intended use, potentially leading to surgical complications.
Surgical professionals using the Blueprint Mixed Reality Coracoid Clamp for shoulder replacements are affected. Patients undergoing these procedures may be at risk if the device malfunctions during surgery.
Check for the catalog number MRUE202 on the clamp, which was packaged in Tornier Blueprint Mixed Reality Instrument Kits (catalog number MRUEGLN). The product was sold from August 2023 through December 2024.
Look for the catalog number MRUE202 on the clamp and the instrument kit catalog number MRUEGLN.
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 with Tornier directly for guidance on next steps.
The product was distributed from August 2023 through December 2024.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1536-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1536-2025 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.
