MicroPort Orthopedics Inc. is recalling 91 units of the HIPTURN FEM HEAD TRIAL 36MM REUSABLE (Model HTHT0036). This recall was issued because the product was distributed within the United States without the required FDA premarket authorization. Consumers and healthcare facilities should stop using this specific trial component immediately.
Using medical devices that have not been cleared or approved by the FDA means their safety and effectiveness have not been formally validated for the U.S. market, which could pose unknown risks to patients during hip surgery. No injuries have been reported to date regarding this authorization issue.
Secondary Device ID: M684HTHT00361. No future lots planned.
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.