Company: Blue Belt Technologies, Inc
Date of Enforcement Report: 10/05/2023
Class II
PRODUCT
Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299
Recall Number:
Z-0041-2024
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
RECALLING FIRM/MANUFACTURER:
Blue Belt Technologies, Inc
VOLUME OF PRODUCT IN COMMERCE:
56 units
DISTRIBUTION:
US Nationwide distribution.
