The Food and Drug Administration of the Ministry of Health has ordered the recall of more than 70,000 bone plates and screws illegally sold to hospitals by a Kaohsiung-based company.
The recall affects 81 hospitals and potentially thousands of patients who received the surgical implants between January and July this year.
The titanium alloy plates and screws were manufactured and sold by Shicheng Precision Technology Co., Ltd. before the company had received the necessary GMP certification.
Deputy head of the Quality Supervision and Administration Section of the FDA Chi Lan-hui (遲蘭慧 ) said that the incident was a “manufacture violation” because the company had distributed the products before receiving the GMP certification required to manufacture medical products.
Chi said that the medical materials are classified as patient-funded (not covered by NHI), and recommended that if patients are worried they should talk to their doctor or seek compensation from the illegal manufacturer according to the consumer protection law.
According to Liberty Times, patients paid NT$40,000 to NT$70,000 for the plates and screws.
The violation was discovered in July, when a GMP certification inspection was carried out. The inspection revealed sales documents that showed the company was already shipping products, and had been doing so since January this year.
While some news reports claim that up to 200 medical institutions have been affected, the Ministry of Health yesterday released a list of 81 hospitals that have used the implants. The list includes many prominent medical institutions such as National Taiwan University, and Tri-Services General Hospital.
The FDA told physicians to pay attention to patients who received the unlicensed products, and to report any adverse reactions to the National Center for Adverse Drug Reactions (email@example.com).
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