China NMPA Product Recall - Metal plate for foot and ankle

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.