Tornier recalls HoloBlueprint Application (MRUE001) for total shoulder arthroplasty due to software and instrumentation problems affecting use. Affected users should contact Tornier for details.
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 HoloBlueprint Application (MRUE0:001) for total shoulder arthroplasty procedures because users report difficulties with software and hardware. This could prevent the system from working as intended during surgery.
The system has been reported to have software and hardware issues that prevent it from working correctly during surgery. These problems can make it difficult to use the product as intended, potentially affecting surgical outcomes.
Surgical teams using the HoloBlueprint Application for total shoulder arthroplasty procedures are affected. Patients undergoing this surgery may be at risk if the system doesn't function properly.
Check for the product name 'HoloBlueprint Application' with catalog number MRUE001. This product is used for total shoulder arthroplasty procedures.
Reach out to Tornier directly for information about the recall and next steps.
The recall states there are reported issues with software and instrumentation that can prevent the system from meeting its intended use, but no specific safety risks are described.
Look for the catalog number MRUE001 on the product label for total shoulder arthroplasty procedures.
The recall does not specify a remedy, so contact Tornier directly for assistance.
We’ve drafted a message you can send Tornier to request your refund or repair — edit it as you like.
Subject: Recall Z-1542-2025 — Tornier Tornier Hello, I own a Tornier that is covered by recall Z-1542-2025 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.
