# China NMPA Product Recall - Longitudinal thoracic shaping artificial titanium rib system

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/4480f905-f289-4a7b-bf45-f9fc4ec83e7d/
Source feed: China

> China NMPA product recall for Longitudinal thoracic shaping artificial titanium rib system by Synthes GmbH published October 14, 2015. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, init

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its longitudinal thoracoplasty artificial titanium rib system.
- Company Name: Synthes GmbH
- Publication Date: 2015-10-14
- Product Name: Longitudinal thoracic shaping artificial titanium rib system
- Recall Level: Level II
- Recall Reason: The manufacturer discovered that the fully extended structure of the affected product, extending to the partially formed final hole, could lead to mechanical failure due to the extension rod breaking, potentially requiring additional surgical intervention to replace the component. In addition to the risk of repeat surgery, potential impacts on patients include pain, loss of deformity correction, and/or soft tissue/internal organ damage.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on behalf of manufacturer Synthes GmbH, initiated a voluntary Class II recall of its Longitudinal Thoracic Reconstruction Artificial Titanium Rib System (Synthes). The recall, reported to the National Medical Products Administration (NMPA) in October 2015 based on a September 2015 company report, resulted from the discovery of a manufacturing defect. The issue involves a partially formed final hole in the product’s extension structure, which could lead to mechanical failure and breakage of the extension rod. This defect carries a risk of serious patient injury, including the need for additional surgical intervention, pain, loss of deformity correction, and potential damage to soft tissues or internal organs. Globally, eight complaints of extension rod breakage have been recorded since 2004, though none were directly attributed to this specific 'partially formed hole' defect, and no related complaints or adverse effects have been reported in China. The regulatory framework for this action falls under the NMPA's medical device recall guidelines. Required actions include notifying affected customers to cease use and manage the products appropriately. In China, 18 affected units were identified, with 3 sold, 8 in inventory, and 7 already destroyed; all remaining affected products are slated for local destruction.

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