# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.keypedia.com/records/china_product_recall/synthes-gmbh/afb45ecf-6d7f-4f2b-8236-a72e7d6afb65
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published September 20, 2015. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall of spec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls trauma surgery instrument packs
- Company Name: Synthes GmbH
- Publication Date: 2015-09-20
- Product Name: Trauma Surgical Instrument Kit
- Recall Level: Level II
- Recall Reason: The manufacturer discovered that during the manufacturing process, micropores may form in the hollow handle of the sciatic nerve retractor. These pores are large enough to allow fluid to enter and exit the hollow handle. Even with meticulous reprocessing and sterilization of the sciatic nerve retractor, leakage of accumulated fluid during use poses a risk of infection and adverse tissue reactions when used on the next patient. If no fluid accumulation and/or discoloration are detected preoperatively, using the instrument in the operating room may delay surgery due to the time required to replace the retractor with a spare. No related complaints or adverse events have been reported in China.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a Class II voluntary recall of specific Trauma Surgical Instrument Kits, as reported by the National Medical Products Administration (NMPA) on September 20, 2015. The manufacturer, Synthes GmbH, identified a manufacturing defect in the hollow handle of the sciatic nerve retractor, a component of the kit (models 03.100.013 and 03.100.014).
The core issue involves the potential development of micropores in the retractor's handle, large enough to allow fluid ingress and egress. This flaw compromises effective cleaning and sterilization processes, leading to a risk of fluid accumulation. Consequently, there is a potential for infection and adverse tissue reactions if contaminated instruments are used in subsequent surgeries. While no related complaints or adverse events have been reported in China, the defect could also cause surgical delays if discovered during preoperative checks.
The recall affects 74 products globally, with 13 units in stock, 15 sold, and 46 on consignment in China. Johnson & Johnson's required actions include notifying all affected customers to immediately cease using the identified products. Furthermore, customers are instructed to return all recalled instruments to the manufacturer or arrange for their local destruction, ensuring patient safety and adherence to medical device standards under NMPA oversight.

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