# China NMPA Product Recall - Anterior cervical plate system

Source: https://www.globalkeysolutions.net/records/china_product_recall/pioneer-surgical-technology-inc/887b6620-3632-445f-a7f5-6a0e17bc4012/
Source feed: China

> China NMPA product recall for Anterior cervical plate system by Pioneer Surgical Technology, Inc. published January 05, 2017. Recall level: Level 3 Recall. Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall for its anterior cervical p

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Pioneer Surgical Technology, Inc. is proactively recalling its anterior cervical plate system.
- Company Name: Pioneer Surgical Technology, Inc.
- Publication Date: 2017-01-05
- Product Name: Anterior cervical plate system
- Recall Level: Level 3 Recall
- Recall Reason: The product thickness does not meet the requirements.
- Discovering Company: Antaikang (Beijing) Consulting Co., Ltd.
- Manufacturing Company: Pioneer Surgical Technology, Inc.
- Summary: Pioneer Surgical Technology, Inc. initiated a voluntary Class III recall for its anterior cervical plate system (Registration No. Guo (Jin) Zi 2013 No. 3462782) after discovering the product's thickness failed to meet established requirements. This regulatory action was formally reported to the China Food and Drug Administration (CFDA), operating under the National Medical Products Administration (NMPA) framework, on December 27, 2016, and publicly announced by the NMPA on January 5, 2017. The recall specifically impacts model/specification 20-355-S, with 42 units distributed in China identified under batch number 189554. This medical device is critical for anterior cervical fixation, addressing various conditions including degenerative disc disease, spinal trauma, and deformities. In response, Pioneer Surgical Technology, Inc. mandated immediate corrective actions: distributors must receive formal notification via email or letter regarding the recall, and all products from the affected batch must be promptly isolated. The manufacturer is expected to issue further processing directives. This incident underscores the stringent regulatory expectations in China for medical device product quality and compliance.

Company: https://www.globalkeysolutions.net/companies/pioneer-surgical-technology-inc/957acdfb-ec89-40f6-90bc-057597e5912b/