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Uncertified orthopedic implants used in Taiwan hospitals: FDA

2019/10/16 21:14:07

Pixabay image for illustrative purpose only

Taipei, Oct. 16 (CNA) The Taiwanese manufacturer of an orthopedic implant is under investigation for allegedly supplying hospitals with falsely certified products, the country's Food and Drug Administration (FDA) said Wednesday.

Ispect Biotech, which makes a plate and screw implant for broken bones, is suspected of falsifying the serial numbers on its products, using the good manufacturing practice (GMP) serial numbers of other certified companies, FDA Director General Wu Shou-mei (吳秀梅) said.

In the period January to July, 80 hospitals in Taiwan, including National Taiwan University Hospital and Tri-Service General Hospital, had procured the uncertified implants, which were used on some 70,000 patients, Wu said.

FDA Division of Risk Management Director Lee Ming-hsin (李明鑫) said Ispect Biotech had commissioned two companies to manufacture the implants, allegedly using serial numbers from certified products.

The case has been handed over to prosecutors for further investigation, according to Wu.

(By Chang Ming-hsuang and Evelyn Kao)