# China NMPA Product Recall - Spinal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/pioneer-surgical-technology-inc/7ba904f9-dff8-4ee2-a276-096451767fbc/
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 voluntary Class III 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 voluntary Class III recall of its spinal fixation system, as announced by the National Medical Products Administration (NMPA) on January 5, 2017. The primary reason for this corrective action was that the length of the product's rods did not meet the specified design and regulatory requirements. This deviation is critical as spinal fixation systems are designed to provide stability and support to the spine, and incorrect rod length could compromise the device's efficacy, potentially impacting patient safety and surgical outcomes.The recall, reported by Antaikang (Beijing) Consulting Co., Ltd., applies to products registered under CFDA 2013 No. 3462783. A Class III recall indicates that while the product defect is unlikely to cause serious adverse health consequences, the deviation from specifications still necessitates corrective action. The company is required to remove the affected batches from distribution. Specific details regarding the models, specifications, and batch numbers of the impacted devices are outlined in the accompanying Medical Device Recall Event Report Form. This action underscores the NMPA's role in overseeing the safety and quality of medical devices within its jurisdiction, ensuring manufacturers adhere to stringent standards.

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