China NMPA Product Recall - Intramedullary nailing tool system

Smith & Nephew, Inc. initiated a voluntary Class III recall of its Intramedullary Nail Tool System (Registration Certificate No. 20161580) following a manufacturing error. This recall was reported to the National Medical Products Administration (NMPA) on December 19, 2018, with the notification published on January 24, 2019. The core issue stemmed from a manufacturing defect: a missing retaining ball within the pull screw guide pin sleeve, which is essential for securely locking the guide pin sleeve in the pull screw drill sleeve. Specific affected components included the 71674032 Pull Screw 3.2mm and the 17MM04909 Guide Pin Sleeve. While the recall information is processed through the NMPA, the document explicitly states that this particular product recall does not impact sales or products distributed within China. Instead, the affected systems were distributed in international markets such as Brazil, Japan, Singapore, and South Africa. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. facilitated the reporting of this global recall under the NMPA's regulatory framework. This action underscores the manufacturer's commitment to product safety and regulatory compliance, ensuring that corrective actions, specifically a voluntary recall, are implemented to address product deficiencies globally, even when direct market impact in China is not present.