# China NMPA Product Recall - General surgical tools for trauma

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-ambiopharm-inc/5e9023ac-57de-4282-8a8c-985bbaa6465c/
Source feed: China

> China NMPA product recall for General surgical tools for trauma by Shanghai Ambiopharm Inc. published July 04, 2017. Recall level: Level 2. The National Medical Products Administration (NMPA) announced a Class II recall on July 4, 2017, for

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Biomet Trauma initiates a recall of general-purpose trauma surgical tools.
- Company Name: Shanghai Ambiopharm Inc.
- Publication Date: 2017-07-04
- Product Name: General surgical tools for trauma
- Recall Level: Level 2
- Recall Reason: The universal surgical tools for trauma patients that we distribute may have abnormalities in their raw materials during testing, potentially increasing the risk of breakage.
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Shanghai Ambiopharm Inc.
- Summary: The National Medical Products Administration (NMPA) announced a Class II recall on July 4, 2017, for universal trauma surgical tools. This voluntary recall was initiated by the manufacturer, Biomet Trauma, with distribution handled by Zimmer Medical (Shanghai) International Trading Co., Ltd. The crucial issue prompting this action was the discovery of potential abnormalities in the raw materials used for these surgical instruments. These material defects are believed to elevate the risk of breakage during surgical procedures, thereby posing a potential safety concern for patients.Under the regulatory framework of the NMPA (formerly CFDA), the company acted proactively to address this quality deficiency. The affected devices are identified by Registration Certificate No.: CFDA (Imported) 2014 No. 1101245. While precise details regarding specific models and batches are contained within the "Recall Event Report Form," the immediate required action involves the systematic retrieval of all impacted universal trauma surgical tools from the market. This demonstrates the company's commitment to upholding patient safety standards and complying with the NMPA's regulations for medical device quality and distribution in China. A Class II recall signifies a situation where the product may cause temporary or reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Company: https://www.globalkeysolutions.net/companies/shanghai-ambiopharm-inc/f65fc19c-d2f1-4161-b4c6-fc5d82566ea0/