medical Class II Updated 2023-10-11

Blue Belt Technologies, Inc recalls Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthropl

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689
View official government recall

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