# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/3c4738d5-58bb-4065-90f4-c6a058a18ec3/
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published July 11, 2016. Recall level: . On July 11, 2016, the National Medical Products Administration (NMPA) published a recall notice rega

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgery instrument kits
- Company Name: Synthes GmbH
- Publication Date: 2016-07-11
- Product Name: Trauma Surgical Instrument Kit
- Recall Reason: The manufacturer found that the affected product failed to pass biosafety assessments for cytotoxicity under specific experimental conditions. The high levels of growth inhibition observed during testing may be due to corrosion at the device's solder joints. If corrosion occurs during use, patients may be exposed to potentially cytotoxic substances, potentially leading to adverse tissue reactions and surgical delays.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: On July 11, 2016, the National Medical Products Administration (NMPA) published a recall notice regarding trauma surgical instrument kits manufactured by Synthes GmbH and distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall, initiated voluntarily by Synthes GmbH, stemmed from biosafety assessment failures. Under specific experimental conditions, the products demonstrated cytotoxicity issues, marked by high growth inhibition levels, potentially due to corrosion at the instruments' weld points. Such corrosion during surgical use could expose patients to cytotoxic substances, leading to adverse tissue reactions and surgical delays. This action falls under the NMPA's regulatory oversight for medical device safety.

Synthes GmbH confirmed that the specific affected product batches were not imported or sold in China. Consequently, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported that no direct corrective actions were required within China for these particular units. However, the NMPA requested that provincial, autonomous region, and municipal food and drug administration bureaus enhance their supervision and management of similar medical devices to safeguard public health. The initial report detailing these findings was submitted by Johnson & Johnson Medical (China) Ltd. on May 26, 2016.

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