# China NMPA Product Recall - Artificial Vertebral System

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/ffeb14bb-6193-418b-8d56-391ab95de9c4/
Source feed: China

> China NMPA product recall for Artificial Vertebral System by Synthes GmbH published December 21, 2015. Recall level: . Synthes GmbH, the manufacturer, in collaboration with its Chinese distributor, Johnson & Johnson (Sh

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls artificial vertebral body systems.
- Company Name: Synthes GmbH
- Publication Date: 2015-12-21
- Product Name: Artificial Vertebral System
- Recall Reason: One side of a batch of artificial vertebral body systems may be missing a toothed screw, which enhances fixation to the vertebral endplate during surgery. If the missing toothed screw is not detected during use, the device's ability to resist implant displacement will theoretically decrease, potentially leading to minor surgical delays or user dissatisfaction.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, the manufacturer, in collaboration with its Chinese distributor, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of its Artificial Vertebral Body System (Registration No.: 20153462090). This recall, reported to the National Medical Products Administration (NMPA) on November 17, 2015, stemmed from a manufacturing issue: a potential missing prong on one side of certain devices (Model/Specification: 495.317). This prong is designed to enhance fixation during surgery.
The primary concern is that a missing prong could theoretically reduce the device's resistance to implant displacement. However, the manufacturer assessed the likelihood of this issue causing increased overall implant displacement or patient injury as very small. The main anticipated consequences were slight surgical delays or user dissatisfaction, as the missing prong is detectable during use. To date, no patient injuries related to this defect have been reported.
Under the NMPA's regulatory oversight, the document specifies that the affected product batch was manufactured in Germany and was not imported into or sold within China. Consequently, no direct corrective actions, such as product retrieval or patient-specific interventions, are required within China. The NMPA requested local food and drug administrations to reinforce supervision of similar products. For patients already implanted with this system, prophylactic removal is not recommended.

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