China NMPA Product Recall - Disposable bone cement mold for temporary femoral prosthesis molding

The National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Biomet Orthopedics, reported by its agent Zimmer Medical (Shanghai) International Trading Co., Ltd. The recall, detailed in a report dated September 27, 2018, concerns disposable bone cement molds for temporary femoral prosthesis molding (NMPA Registration No.: 20163461466). The primary reason for the recall is a potential batch mixing risk identified by the manufacturer, affecting specific batches including 705550, 705570, and 705580 for product models 431207 and 431209. These molds are intended for preparing temporary femoral prostheses for revision replacement due to hip prosthesis infection. While the recall impacts regions such as Canada, Australia, the EU, and the USA, it is important to note that the specific problematic batches were not sold or distributed within China. Therefore, no direct actions are required for products currently in the Chinese market, as this serves as a proactive measure by Zimmer Biomet to address the identified quality control issue globally.