Stryker Blueprint Software recall: Software Issue
Stryker Blueprint Software, Catalog #BPUE001.
Why was Stryker Blueprint Software recalled?
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
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?
Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
- Product
- Stryker Blueprint Software, Catalog #BPUE001.
- Recalling firm
- Tornier S.A.S.
- Distribution
- US Nationwide distribution in the states of FL, KY, NJ, and WI.
- Recall date
- May 29, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)