Synovo Production is recalling 2,941 units of various hip and femur medical device components, including Acetabular Fixation Cups, Bearings, and Femoral Resurfacing Cups. These orthopedic implants were marketed and sold without the required FDA clearance or approval, meaning their safety and effectiveness have not been verified by federal regulators. The recall affects components sold nationwide and specifically within the state of Washington.
Because these devices were not cleared or approved by the FDA, there is no guarantee that they meet federal safety and performance standards for surgical implants. Using unvetted medical components in joint replacement surgeries could lead to unpredictable device failure, the need for additional surgeries, or other health complications.
Consultation with healthcare providers
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 · FDA Press Release · 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.