# China NMPA Product Recall - Trauma surgical instruments (trade name: SYNTHES); Orthopedic surgical instruments - reaming, perfusion, and suction systems (trade name: RIA)

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/896eb9b1-9e25-4f7b-8604-c590b174495b/
Source feed: China

> China NMPA product recall for Trauma surgical instruments (trade name: SYNTHES); Orthopedic surgical instruments - reaming, perfusion, and suction systems (trade name: RIA) by Synthes GmbH published July 16, 2015. Recall level: . Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the National Medical Products A

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling trauma surgery tools and orthopedic surgical instruments – reaming, perfusion, and suction systems.
- Company Name: Synthes GmbH
- Publication Date: 2015-07-16
- Product Name: Trauma surgical instruments (trade name: SYNTHES); Orthopedic surgical instruments - reaming, perfusion, and suction systems (trade name: RIA)
- Recall Reason: The reason the manufacturer issued the on-site safety notice is to inform customers that the manufacturer has added a precautionary statement to the "Reaming, Perfusion, and Suction System (RIA) Surgical Technique Guidelines" because there have been reports that the RIA drive shaft, tubular assembly components, and reamer head may break when incorrectly assembled or used, ultimately resulting in instrument fragments. Removing medullary fragments may delay surgery; if fragments remain, they may cause adverse tissue reactions. If the "finger/tip" of the reamer head and/or the hexagonal portion of the reamer shaft breaks, the reamer head may damage the medullary cavity, potentially causing patient pain.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., acting under the National Medical Products Administration (NMPA) framework, initiated a voluntary recall on July 16, 2015, for specific trauma surgical tools and orthopedic surgical instruments. The recall primarily targeted the Reaming, Perfusion, and Suction System (RIA), manufactured by Synthes GmbH. The main issue identified was the potential for the drive shaft, tubular assembly, and reamer head components to break during incorrect assembly or improper use. This could lead to instrument fragments remaining within the surgical site, causing potential surgical delays, adverse tissue reactions, or direct patient harm and pain. As a required action, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. destroyed all three affected product units imported into China, none of which had been sold. Additionally, the manufacturer issued an on-site safety notice and incorporated a precautionary statement into the RIA Surgical Technique Guidelines to inform users of these risks. Since the products did not reach the market, no further investigative or summary reports were deemed necessary beyond the initial notification to the Shanghai Food and Drug Administration.

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