Stryker HoloBlueprint Application Medical Device Software Functionality Recall
Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text does not report any hospitalizations, injuries, or illnesses; the hazard is operational/functional rather than a direct safety threat. Compliance with Class II classification and lack of reported adverse health outcomes supports a Moderate severity rating.
Plain-English summary
Stryker is recalling the HoloBlueprint Application, Catalog Number MRUE001, a mixed reality guidance instrumentation system used for total shoulder arthroplasty procedures. The recall was initiated because the device has an elevated complaint rate related to difficulties using the system.
The most commonly reported complaints involve impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. These issues are multifactorial in nature but in each reported case prevent the system from meeting its intended use.
The affected device was distributed in the United States (TX, MN, AK, PA, MA, TN, ID) as well as France, Canada, and Ireland. A total of 14 units were recalled. Stryker is the recalling firm.
Patients and healthcare providers who have this device should contact Stryker for further guidance regarding the malfunction issues affecting the system.
The recalled product
- Product
- stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-malfunction
- instrumentation-failure
- functional-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GTIN 03700434016505
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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