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William Joseph Zinnanti, Adulteration Of Medical Devices, Pennsylvania 2012

A former Hershey resident has been sentenced to prison for introducing adulterated medical devices into interstate commerce.

William Joseph Zinnanti, 44, of Mountain View, California, was sentenced to four months’ imprisonment by U.S. District Court Senior Judge William W. Caldwell on May 2012 for violating Federal Food and Drug laws.

The adulterated medical devices were manufactured by Zinnanti Surgical Design, LLC, a business Zinnanti owned and operated while residing in Hershey, Pennsylvania. The medical device in question was the Bayonet Electro-Surgical Pencil, which was sold to hospitals and used by surgeons to cut and cauterize tissue during back surgery.

According to Assistant U.S. Attorney Joseph Terz, the surgical pencils were adulterated because the methods, facilities, and controls used for their manufacture, packing, and storage did not meet current good manufacturing practices. Zinnanti acted with the intent to defraud and mislead the FDA regarding his manufacturing procedures.

The FDA’s Office of Criminal Investigations conducted the investigation, and the case was prosecuted with the assistance of the FDA’s Office of Chief Counsel.

A nationwide and international recall of the device was instituted in 2006 after questions surrounding the sterility of the device came to light. Anyone seeking further information regarding the recall should contact the FDA Division of Small Manufacturers International and Consumer Assistance at 1-800-638-2041.

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