FDA-Device2023-10-11Class II
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Blue Belt Technologies, Inc
Hazard
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
Sold states
US Nationwide distribution.
Affected count
56 units
Manufactured in
2875 Railroad St, N/A, Pittsburgh, PA, United States
Products
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0041-2024Don't want to check this manually?
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