Orthofix U.S. LLC has recalled 624 units of Virata Preassembled Polyaxial Screws used within the Virata Spinal Fixation System. These surgical screws, manufactured in various sizes ranging from 5.5mm to 8.5mm, do not meet required performance standards. This recall was initiated voluntarily by the firm to ensure patient safety and device reliability.
Screws that do not meet performance standards may fail mechanically or provide inadequate fixation for spinal surgery. This could result in surgical complications, the need for additional medical intervention, or the failure of the spinal implant system.
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
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