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Blueprint Mixed RealityRecalls & reported problems across all models

Tornier · 8 models in the FDA device registry

Data updated Oct 16, 2026 from official FDA records · Editorial policy

9 open recalls name at least one Blueprint Mixed Reality model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls
9

We found 8 models of Blueprint Mixed Reality by Tornier in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

9 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Blueprint Mixed Reality recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

  1. Mar 5, 2025Open, Classified

    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.

    Z-1542-2025 · Root cause: Device Design · Recall details · FDA record ↗

  2. Mar 5, 2025Open, Classified

    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.

    Z-1540-2025 · Root cause: Device Design · Recall details · FDA record ↗

  3. Mar 5, 2025Open, Classified

    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.

    Z-1539-2025 · Root cause: Device Design · Recall details · FDA record ↗

  4. Mar 5, 2025Open, Classified

    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.

    Z-1538-2025 · Root cause: Device Design · Recall details · FDA record ↗

  5. Mar 5, 2025Open, Classified

    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.

    Z-1537-2025 · Root cause: Device Design · Recall details · FDA record ↗

  6. Mar 5, 2025Open, Classified

    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.

    Z-1536-2025 · Root cause: Device Design · Recall details · FDA record ↗

  7. Mar 5, 2025Open, Classified

    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.

    Z-1535-2025 · Root cause: Device Design · Recall details · FDA record ↗

  8. Mar 5, 2025Open, Classified

    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.

    Z-1534-2025 · Root cause: Device Design · Recall details · FDA record ↗

  9. Dec 18, 2024Open, Classified

    The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

    Z-0846-2025 · Root cause: Device Design · Recall details · FDA record ↗

Blueprint Mixed Reality models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

Other Tornier products

All Tornier devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page