Onkos Surgical, Inc. has recalled one unit of the My3D Personalized Solutions Humeral Cup, Model Number C24-0223-0003. This device is a component used in custom shoulder replacement surgeries. The recall was initiated because the required final inspections were not performed on the finished product before it was released and distributed.
If an implantable medical device does not undergo required final quality inspections, there is a risk that it may not meet design specifications. This could potentially lead to device failure or surgical complications for the patient.
Component of a Custom Constrained Shoulder Arthroplasty Device.
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.