stryker HoloBlueprint Application recall: Software Issue
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Why was stryker HoloBlueprint Application recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN 03700434016505
- Product
- stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
- Recalling firm
- Tornier S.A.S.
- Quantity
- 14
- Distribution
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Recall date
- April 16, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)