Real Intelligence CORI RI.KNEE v2.0 TKA recall: Software Issue
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Why was Real Intelligence CORI RI.KNEE v2.0 TKA recalled?
CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis
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?
UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
- Product
- Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
- Recalling firm
- Blue Belt Technologies, Inc
- Quantity
- 56 units
- Distribution
- US Nationwide distribution.
- Recall date
- October 11, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)