Former Hershey Resident Sentenced For Adulteration Of Medical Devices
The United States Attorney's Office for the Middle District of Pennsylvania announced that William Joseph Zinnanti, age 44, of Mountain View, California, was sentenced today, in Harrisburg, to four months’ imprisonment by U.S. District Court Senior Judge William W. Caldwell for introducing adulterated medical devices into interstate commerce in violation of Federal Food and Drug laws.
According to information presented by Assistant U.S. Attorney Joseph Terz, from 2005 to 2007, while residing in Hershey, Pennsylvania, Zinnanti was the President and Owner of a business known as Zinnanti Surgical Design, LLC, which manufactured a medical device known as the Bayonet Electro-Surgical Pencil. The device was sold mainly to hospitals. Surgeons used this device to cut and cauterize tissue surrounding the patient's thoracic vertebrae to allow access to the thoracic disk space during back surgery.
The surgical pencils were adulterated because the methods, facilities, and controls Zinnanti used for the manufacture, packing, and storage of the product did not comport with current good manufacturing practice to ensure that the devices were safe and effective and in compliance with the Federal Food, Drug, and Cosmetic Act. Zinnanti acted with the intent to defraud and mislead the FDA with regard to the manufacturing procedures he had in place.
Zinnanti was charged in May 2012 and pleaded guilty in June 2012.
According to United States Attorney Peter J. Smith, after questions surrounding the sterility of the device came to light in 2006, a nationwide and international recall was instituted. Anyone seeking further information regarding the recall should contact the FDA Division of Small Manufacturers International and Consumer Assistance at 1-800-638-2041.
This investigation was conducted by the Food and Drug Administration, Office of Criminal Investigations. The case was prosecuted with the assistance of FDA's Office of Chief Counsel.