Blue Belt Technologies, Inc. has recalled 56 units of its Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software, specifically version 2.0 (2.0.0.5). The recall was initiated because the software may miss a critical planning stage during surgeries involving significant knee deformation (outside the range of 3 degrees valgus to 7 degrees varus) when the surgeon uses the posterior condylar axis as a reference. This software defect could lead to improper surgical planning and potential alignment issues during knee replacement procedures. Consumers and healthcare providers should contact the manufacturer or their healthcare provider for further instructions regarding this software error.
The software error prevents surgeons from seeing a necessary planning stage when operating on patients with significant knee deformities. This missing information could result in incorrect placement or alignment of the knee implant, potentially leading to surgical complications or the need for corrective procedures.
Manufacturer notification and software update/mitigation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.