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May 25, 2017

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Fake medical equipment spurs warning from FDA

TAIPEI--The Food and Drug Administration (FDA) called on health institutions nationwide Saturday to check whether their medical equipment has been approved for use, after prosecutors busted a company allegedly producing and selling unlicensed bone plates and screws.

Approved medical devices should be licensed and the information on the outer packaging should match the content of the license, according to a statement released by the administration.

The statement came as prosecutors seized about 13,000 items from Stephen Fan Trading Co., Ltd. The Taipei-based company was reported to have manufactured and distributed fake plates and screws under the name of a U.S. medical device manufacturer.

However, Lin Hsin-hui, a section chief of the FDA's Medical Device and Cosmetics Department, said that "there will be no product recall at the moment."

She explained that prosecutors have yet to prove that the trading company has violated the regulations.

About 100 hospitals nationwide have bought products from the company, according to media reports.

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