Blue Belt Technologies recalls Real Intelligence CORI RI.KNEE v2.0 TKA software version 2.0 (2.0.0.5) due to missing planning for significant knee deformations, potentially leading to incorrect surgical placement.
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
Blue Belt Technologies recalls a specific software version for knee surgery planning that may not account for severe knee deformities, risking incorrect surgical placement. This could lead to improper joint alignment and complications after surgery.
The software version 2.0 (2.0.0.5) lacks a critical planning step for cases where the knee is significantly deformed. This could cause incorrect surgical placement if the surgeon defines the femoral rotation using the posterior condylar axis without proper adjustment for deformity.
Surgeons using Real Intelligence CORI RI.KNEE v2.0 TKA software version 2.0 (2.0.0.5) for knee replacements are affected. Those with significant knee deformations outside the 3-degree valgus to 7-degree varus range are at higher risk.
Check for the software version 2.0 (2.0.0.5) with product number ROB10299 and UDI (01) 00885556773338. Lot numbers 51141585, 51108475, and 51108689 are also associated with this recall.
Verify the software version is 2.0 (2.0.0.5) with product number ROB10299 and UDI (01) 00885556773338.
The software version 2.0 (2.0.0.5) may not properly plan for significant knee deformations outside the 3-degree valgus to 7-degree varus range, potentially causing incorrect surgical placement.
Knee deformities outside the 3-degree valgus to 7-degree varus range, which can occur in cases of significant knee deformation.
Check for product number ROB10299, UDI (01) 00885556773338, and lot numbers 51141585, 51108475, or 51108689.
We’ve drafted a message you can send Blue Belt Technologies to request your refund or repair — edit it as you like.
Subject: Recall Z-0041-2024 — Blue Belt Technologies Blue Belt Technologies Hello, I own a Blue Belt Technologies that is covered by recall Z-0041-2024 from Blue Belt Technologies. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
