Device Exec Indicted Over Adulterated Surgical Pencil

A news release says that Zinnanti was president and owner of Zinnanti Surgical Design from 2005–2007. The company, which its Web site says he co-founded, manufactured the Bayonet Electro-Surgical Pencil that was sold primarily to hospitals and used by surgeons to cut and cauterize tissue surrounding a patient’s thoracic vertebrae to allow access to the thoracic back space during back surgery.

The devices were adulterated, the criminal information says, due to current good manufacturing practice violations. The government says that Zinnanti acted with the intent to defraud and mislead FDA about the manufacturing procedures he had in place.

He faces a prison term of up to three years and a fine of $250,000. FDA’s Office of Chief Counsel assisted in the investigation.