Ethical And Regulatory Issues In Knee Surgery

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Due to such safety concerns, the manufacturers are facing device recalls for the device such as DePuy Synthes, Stryker, Smith &Nephew, Biomet and Zimmer [2]. As the knee surgery is most common now a day i.e. around 7 million of Americans are living with the surgery. Moreover, the regulatory issues with the devices are leading to the serious issues to the public health with the implantable device. Considering the regulatory aspects, the knee joint prostheses were the post-amendments device classified into class III under section 513(f)(2) of the act. After the petition submitted by Orthopedic Surgical Manufacturers Association (OSMA), the Panel recommended that this device can be reclassified from class III to class II at the public meeting

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