# China NMPA Product Recall - Bone screws

Source: https://www.globalkeysolutions.net/records/china_product_recall/aap-implantate-ag/7b792f05-c98a-4f76-a359-3db59f2b9c79/
Source feed: China

> China NMPA product recall for Bone screws by aap Implantate AG published January 24, 2019. Recall level: Level 3 Recall. aap Implantate AG has initiated a voluntary Level Three recall for specific batches of its bone scre

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: aap Implantate AG Bone-Connecting Screw Active Recall
- Company Name: aap Implantate AG
- Publication Date: 2019-01-24
- Product Name: Bone screws
- Recall Level: Level 3 Recall
- Recall Reason: The thread diameter of the medical device tested by the National Inspection Team did not meet the standard.
- Discovering Company: Beijing Baiyou Huatai Medical Technology Co., Ltd.
- Manufacturing Company: aap Implantate AG
- Summary: aap Implantate AG has initiated a voluntary Level Three recall for specific batches of its bone screws, following a critical finding that their thread diameter failed to conform to national medical device sampling inspection standards. This significant non-compliance was reported by Beijing Baiyou Huatai Medical Technology Co., Ltd., the entity responsible for distributing these products. The affected devices, identified under registration number 国械[20163465092], are subject to this recall, which was announced on January 24, 2019.
The National Medical Products Administration (NMPA) of China serves as the overarching regulatory body overseeing this action, ensuring compliance with established medical device safety and quality protocols. A Level Three recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. However, it still mandates removal from the market to uphold product integrity and regulatory adherence. Detailed information regarding the specific models, specifications, and batch numbers implicated in this recall is thoroughly documented in the supplementary "Medical Device Recall Event Report Form." This proactive measure by aap Implantate AG, under the supervision of the NMPA, reinforces the stringent regulatory framework designed to safeguard public health and maintain the quality of medical devices circulated within China's healthcare system.

Company: https://www.globalkeysolutions.net/companies/aap-implantate-ag/e27a9002-6dce-4994-ac80-e5377c0e9a44/