Device product
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Z-0041-2024
Product summary
- Event
- Event 93046
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0041-2024
Official wording
Reason: 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
Code information: UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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