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

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

Details from the source

Reason for recall: 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 Distribution: US Nationwide distribution. Quantity: 56 units Lot/code info: UDI: (01) 00885556773338 Lot Numbers: 51141585, 51108475, 51108689

UPC codes

00885556773338

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.