FDA permits 'export only' medical devices not for use in US

 

November 29, 2018



Australian Army veteran Wolfgang Neszpor was stunned when he heard his recently repaired shoulder squeak.

"You could really hear it," he said.

He recalled when the surgeon examined him and lifted up his arm, "It was a stupid amount of pain." Two months earlier, Neszpor, 36, had gotten a new shoulder joint, a PyroTITAN made by Integra LifeSciences of New Jersey.

Neszpor lives in Australia, where his operation was performed. He believed the Made in the USA label meant he would be fixed with state-of-the-art technology.

What he did not know is that even though it was made in the USA, the U.S. Foo...



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