# China NMPA Product Recall - Intervertebral facet joint fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/cf083e53-e0bc-4672-acab-f2737c1da401/
Source feed: China

> China NMPA product recall for Intervertebral facet joint fixation system by Synthes GmbH published December 29, 2016. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its facet joint fixation system.
- Company Name: Synthes GmbH
- Publication Date: 2016-12-29
- Product Name: Intervertebral facet joint fixation system
- Recall Level: Level II
- Recall Reason: Post-marketing clinical studies of the facet joint fixation system have identified that patients who receive the system alone may show radiographic signs of non-fusion. Therefore, Synthes will remove the section regarding "single use in cases of segmental stabilization" from its product information and surgical technique guidelines.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its Intervertebral Facet Joint Fixation System, as reported by the National Medical Products Administration (NMPA) on December 29, 2016. Post-marketing clinical studies revealed that patients receiving the system alone, without bone grafting, might experience radiographic signs of non-fusion. The primary issue was the existing product instructions and surgical guidelines which permitted "single use in cases of segmental stability." The manufacturer, Synthes GmbH, through Johnson & Johnson, is taking corrective action globally. This involves removing the problematic "single use" indication from all product instructions and surgical technique guidelines to ensure appropriate usage. While 16 affected products were imported into China for registration purposes, they were consumed and not commercially sold, meaning no product retrieval from the Chinese market is required. No patient complaints or adverse events related to this specific issue have been reported to date. This proactive recall aims to mitigate potential risks associated with the device's usage as a standalone solution, reinforcing patient safety and product efficacy.

Company: https://www.globalkeysolutions.net/companies/synthes-gmbh/77a06946-ba7a-4bf2-916a-600eabfb0ce7/