Blue Ortho TKA Pro v2.1 software installed on the recall: Software Issue
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference…
Why was Blue Ortho TKA Pro v2.1 software installed on the recalled?
The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
TKA Pro v2.1 software
- Product
- Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference…
- Recalling firm
- Blue Ortho
- Quantity
- 7 units
- Distribution
- AZ, CA, FL, TN Foreign: Italy
- Recall date
- February 19, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)