# China NMPA Product Recall - Trauma Surgical Instrument Kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/synthes-gmbh/6c58c00c-7093-4511-aa0e-f8520073e38e/
Source feed: China

> China NMPA product recall for Trauma Surgical Instrument Kit by Synthes GmbH published April 13, 2016. Recall level: . Synthes GmbH, a Johnson & Johnson Medical company, initiated a voluntary global recall of specific t

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Synthes GmbH recalls trauma surgery instrument kits
- Company Name: Synthes GmbH
- Publication Date: 2016-04-13
- Product Name: Trauma Surgical Instrument Kit
- Recall Reason: The manufacturer has found that the affected products may be incompatible with the corresponding protective sleeves, causing interference between the two instruments during use. This incompatibility may lead to surgical delays, damage to surrounding structures, bone injury, adverse tissue reactions, and abnormal bone healing.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Synthes GmbH
- Summary: Synthes GmbH, a Johnson & Johnson Medical company, initiated a voluntary global recall of specific trauma surgical instrument kits (Model 356.706, registration number: 国械备20150914). This action was reported to the National Medical Products Administration (NMPA) in China in March 2016 and publicly announced on April 13, 2016.
The core issue identified was an incompatibility between the surgical instrument kits and their corresponding protective sleeves. This defect could cause interference during use, potentially leading to adverse events such as surgical delays, damage to surrounding tissues, bone injury, adverse tissue reactions, and abnormal bone healing.
Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. served as the responsible entity for the recall within China under the NMPA's regulatory framework. Crucially, the company confirmed that none of the affected product batches were imported into or sold in China. Therefore, no direct corrective actions, such as product retrieval or replacement, were necessary within the Chinese market. The NMPA, in turn, requested provincial food and drug administrations to enhance their supervision of similar medical devices. This proactive recall highlights the company's commitment to patient safety worldwide, even in regions unaffected by product distribution.

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