stryker Blueprint Mixed Reality Instrument Kit recall: Software Issue
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Why was stryker Blueprint Mixed Reality Instrument Kit 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?
All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN x
- Product
- stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Recalling firm
- Tornier S.A.S.
- Quantity
- N/A
- 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)