# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/6d0cb6c9-36d7-46f4-ab4c-0ee51eb2e35e/
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published August 19, 2015. Recall level: Class II Recall. On August 19, 2015, the National Medical Products Administration (NMPA) reported a Class II voluntar

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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: 2015-08-19
- Product Name: Trauma Surgical Instrument Kit
- Recall Level: Class II Recall
- Recall Reason: The manufacturer reviewed complaints and found that the incidence of intraoperative breakage of the hexagonal tip of the affected product was higher than expected. Excessive force may cause the hexagonal tip of the hollow hexagonal screwdriver handle to shatter during use. Removing broken fragments may delay surgery; changing tools or using instruments with styes or caps may also cause delays. Furthermore, failure to remove non-metallic fragments from the patient may result in adverse tissue reactions. 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: On August 19, 2015, the National Medical Products Administration (NMPA) reported a Class II voluntary recall initiated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall concerns specific Trauma Surgical Instrument Kits, particularly a "screwdriver for orthopedic use" (model 356.714) manufactured by Synthes GmbH. The core issue identified was a higher-than-expected rate of breakage of the screwdriver's hexagonal tip during surgery, especially under excessive force. This defect could lead to significant surgical delays, as fragments might need to be removed, and alternative instruments or tool changes would be required. Critically, if stainless steel fragments were not fully removed from a patient, there was a risk of adverse tissue reactions and further complications. While no complaints or adverse events were reported in China, 81 affected units were imported, with 37 sold and 43 consigned. Under the NMPA's regulatory framework, the company's required actions included notifying all affected distributors to immediately stop using the recalled products. Furthermore, distributors were instructed to either return the faulty instruments to the manufacturer or ensure their local destruction, aiming to prevent further patient exposure to the defective devices.

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