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FDASeptember 7, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Ongoing

Brands named

blue belt technologiesblueblue belt

UPCs

00885556773338

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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