# China NMPA Product Recall - Spinal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/pioneer-surgical-technology-inc/b2ffe912-ebc4-4450-9c03-a2d7519d3ac4/
Source feed: China

> China NMPA product recall for Spinal fixation system by Pioneer Surgical Technology, Inc. published January 05, 2017. Recall level: Level 3 Recall. Pioneer Surgical Technology, Inc. initiated a Class III voluntary recall of its Spinal Fixation Syst

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Pioneer Surgical Technology, Inc. is issuing a voluntary recall for its spinal fixation systems.
- Company Name: Pioneer Surgical Technology, Inc.
- Publication Date: 2017-01-05
- Product Name: Spinal fixation system
- Recall Level: Level 3 Recall
- Recall Reason: The length of the rod 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 Class III voluntary recall of its Spinal Fixation System in China, as reported by the National Medical Products Administration (NMPA) on January 5, 2017. The recall, detailed in a report dated December 27, 2016, addresses a critical issue where the length of the product's rod did not meet specified requirements. The affected medical device, registered under CFDA 2013 No. 3462783, is a non-cervical spine fixation system intended for various conditions including degenerative disc disease, trauma, and spinal deformities. A total of 46 units from batch number 202332 were imported and sold in China. In response to this product deficiency, Pioneer Surgical Technology, Inc. mandated several corrective actions. These include sending formal email notifications to distributors to retrieve the specific batch of affected products, ensuring the immediate isolation of all identified units, and awaiting further instructions from the manufacturer regarding additional steps. This recall underscores the importance of stringent adherence to product specifications in ensuring the quality and safety of medical devices.

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