CFDA announces that a number of medical device products do not meet the standards

Recently, Xinhua News Agency reporter learned from the State Food and Drug Administration that the Food and Drug Administration has organized quality supervision and sampling on 122 varieties of metal spine screws and metal spine rods, and found that one batch of metal spinal rods does not meet the standard.
According to the announcement of the Food and Drug Administration, Pioneer Surgical Technology, Inc. The size of the production of one batch of metal spinal rods (spinal fixation system - orthopedic rods, hexagonal ends) does not meet the standard. The sampling inspection items of the remaining 121 batches of products all meet the standard requirements. The Food and Drug Administration has required the food and drug supervision and administration department of the locality of the enterprise to investigate and deal with relevant enterprises in accordance with relevant regulations. The State Food and Drug Administration has emphasized that relevant medical device manufacturers should conduct risk assessments for products that do not meet the standards and products that do not meet the standards, determine the recall level according to the severity of medical device defects, and actively recall and publicly recall information.

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Shandong Shengli Bioengineering Co., Ltd , https://www.shenglipharm.com