Blue Belt Technologies, Inc recalls Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102…

Recall date

September 7, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0041-2024

FDA classification

Class II

Brand / firm

Blue Belt Technologies, Inc

Sold / distributed

US Nationwide distribution.

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299