In what world do physicians have to disclose to patients that their surgical procedure will be performed with previously used surgical instruments in order to avoid criminal liability of fraud pursuant to 21 U.S.C. § 331(k) and Section 301(k) of the Food, Drug and Cosmetic Act? And in what world does adulteration of a surgical device occur when that device is used for its intended purpose?

In what world do physicians have to disclose to patients that their surgical procedure will be performed with previously used surgical instruments in order to avoid criminal liability of fraud pursuant to 21 U.S.C. § 331(k) and Section 301(k) of the Food, Drug and Cosmetic Act? And in what world does adulteration of a surgical device occur when that device is used for its intended purpose?