In order to strengthen the quality supervision and management of medical devices and ensure the safe and effective use of medical device products, the State Food and Drug Administration has organized quality supervision and sampling on products of 122 varieties of metal spine screws and metal spine rods. The results of the random inspection are now announced as follows:
1. A medical device product that is not in compliance with the standard for sampling items, and one batch of one variety of one medical device manufacturer. Specifically:
Metal spine stick 1 company 1 batch of products. One batch (spinal fixation system - orthopedic rod, hexagonal end) manufactured by Pioneer Surgical Technology, Inc., does not meet the standard specifications.
The above sampling does not meet the specific conditions of the product specified in the standard, see Annex 1.
2. All the sampling equipments that meet the standard requirements involve 121 batches of 2 varieties of 60 medical device manufacturers, see Annex 2.
3. The State Food and Drug Administration has requested the food and drug supervision and administration department of the locality to comply with the Regulations on the Supervision and Administration of Medical Devices and the General Office of the Food and Drug Administration to further strengthen medical devices. Notice of Sampling Work (Food and Drug Supervisory Office [2016] No. 9), investigate and deal with relevant enterprises.
Relevant medical device manufacturers shall 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 the medical device defects, and actively recall and publicly recall the information. The provincial food and drug supervision and administration department of the enterprise shall supervise the recall of the enterprise, and shall not recall the recall of the organization; if it is found that the medical device product does not meet the standards and cause harm to the human body or there is evidence to prove that it may endanger human health, it shall be taken. Suspension of emergency control measures for production, import, operation and use. Relevant provincial food and drug supervision and administration departments should urge enterprises to ascertain the reasons as soon as possible, formulate rectification measures and rectify them in time, and the relevant disposal situation will be announced to the public before April 14, 2017.
