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Defendant Sentenced for Medical Device Adulteration
William Joseph Zinnanti, a 44-year-old resident of Mountain View, California, has been sentenced to four months in prison by U.S. District Court Senior Judge William W. Caldwell in Harrisburg, Pennsylvania.
The sentence comes after Zinnanti was found guilty of introducing adulterated medical devices into interstate commerce in violation of Federal Food and Drug laws. This charge stems from his operation of Zinnanti Surgical Design, LLC, a business he owned and operated in Hershey, Pennsylvania from 2005 to 2007.
As the President and Owner of Zinnanti Surgical Design, LLC, Zinnanti manufactured a medical device known as the Bayonet Electro-Surgical Pencil. This device was sold to hospitals and used by surgeons to cut and cauterize tissue surrounding the patient’s thoracic vertebrae during back surgery.
However, an investigation revealed that the surgical pencils manufactured by Zinnanti were adulterated due to inadequate manufacturing practices. Zinnanti’s methods, facilities, and controls did not comply with current good manufacturing practice, putting patients at risk. Furthermore, Zinnanti intentionally misled the FDA about his manufacturing procedures.
The adulterated medical devices were sold to hospitals nationwide and internationally. In 2006, a recall was initiated after questions surrounding the sterility of the device came to light. Anyone seeking further information regarding the recall can contact the FDA Division of Small Manufacturers International and Consumer Assistance at 1-800-638-2041.
Zinnanti was charged in May 2012 and pleaded guilty in June 2012. The investigation was conducted by the Food and Drug Administration, Office of Criminal Investigations, with the assistance of FDA’s Office of Chief Counsel.
The case highlights the importance of ensuring that medical devices are manufactured with the highest standards of safety and effectiveness. Zinnanti’s actions put patients’ lives at risk, and his sentence serves as a warning to others who may engage in similar practices.
Key Facts
- State: Pennsylvania
- Category: White Collar Crime
- Source: DOJ Press Release â†â€â€
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