# China NMPA Product Recall - Metal plate for foot and ankle

Source: https://www.globalkeysolutions.net/records/china_product_recall/general-medical-equipment-shanghai-co-ltd/a1af2467-d8c8-406e-85d7-842110759a81/
Source feed: China

> China NMPA product recall for Metal plate for foot and ankle by General Medical Equipment (Shanghai) Co., Ltd. published December 05, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a notice on December 5, 2018, detailing a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: General Medical Devices (Shanghai) Co., Ltd. is voluntarily recalling metal bone plates for the foot and ankle.
- Company Name: General Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2018-12-05
- Product Name: Metal plate for foot and ankle
- Recall Level: Level 3 Recall
- Recall Reason: Due to a malfunction in the supplier's sealing equipment, the sterilization packaging sealing width of some models/batch numbers of the foot and ankle metal bone plates was inappropriate, which affected the product's performance.
- Discovering Company: General Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: General Medical Equipment (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) issued a notice on December 5, 2018, detailing a voluntary Class III recall initiated by General (Shanghai) Medical Devices Co., Ltd. The recall, referenced under notice number [沪食药监械主召2018-278], pertains to specific models and batches of the company's foot and ankle metal bone plates (Registration Certificate No.: 国械注进20163461050).

The primary concern prompting this action was a malfunction in the supplier's sealing equipment, leading to an inappropriate sterilization packaging sealing width for some affected products. This manufacturing defect has the potential to compromise the product's performance and integrity. Under the NMPA's regulatory framework, General (Shanghai) Medical Devices Co., Ltd. reported this issue and is undertaking a voluntary recall to address the potential impact on product functionality. A Class III recall indicates that while the product defect is unlikely to cause serious adverse health consequences, it warrants removal from the market to prevent potential issues. Further details on the affected products are provided in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/general-medical-equipment-shanghai-co-ltd/e78bec1e-b5e6-44db-9c62-8b77dec44ed4/