Inspections, Compliance, Enforcement, and Criminal Investigations
May 15, 2012: Former Hershey Resident Charged Federally with Adulteration of Medical Devices
The United States Attorney's Office for the Middle District of Pennsylvania announced the filing of a Criminal Information yesterday charging William Joseph Zinnanti, age 42, of Mountain View, California, with introducing adulterated medical devices into interstate commerce in violation of Federal Food and Drug laws.
According to United States Attorney Peter J. Smith, 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 Information alleges that the surgical pencils were adulterated because the methods, facilities, and controls Zinnanti used for the manufacture, packing, and storage of the Bayonet Electro-Surgical Pencil 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. According to the charges in the Information, Zinnanti acted with the intent to defraud and mislead the FDA with regard to the manufacturing procedures he had in place.
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.
Zinnanti faces a term of imprisonment of up to three years and a fine of $250,000.00.
This investigation was conducted by the Food and Drug Administration, Office of Criminal Investigations. Assistant United States Attorney Joseph J. Terz is prosecuting the case, with the assistance of FDA's Office of Chief Counsel.
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An Indictment or Information is not evidence of guilt but simply a description of the charge made by the Grand Jury and/or United States Attorney against a defendant. A charged Defendant is presumed innocent until a jury returns a unanimous finding that the United States has proven the defendant’s guilt beyond a reasonable doubt or until the defendant has pled guilty to the charges.