Tornier recalls Blueprint Mixed Reality Instrument Check Block (MRUE203) due to software and hardware issues affecting use in total shoulder arthroplasty procedures. Affected units were distributed 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 Instrument Check Block (MRUE203) because users report problems with software and hardware that prevent the system from working properly during shoulder surgery. This could lead to difficulties in the surgical process if the instrument fails to function as intended.
The instrument has been reported to have software and hardware issues that prevent it from functioning correctly during surgery. These problems can cause difficulties in the surgical process, but the specific risks are not severe enough to cause serious injury in normal use.
Orthopedic surgeons and surgical teams using the Blueprint Mixed Reality Instrument Check Block for total shoulder arthroplasty procedures are most at risk. Patients undergoing these surgeries may be affected if the instrument fails during the procedure.
Check for the catalog number MRUE203 on the instrument. The product was distributed from August 2023 through December 2024 and is used in total shoulder arthroplasty procedures.
Look for the catalog number MRUE203 on the instrument or its packaging.
The recall indicates reported issues with software and hardware that may affect use, but the product is not considered unsafe in normal use.
The recall does not specify a remedy, so no action is required at this time.
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-1537-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1537-2025 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.
