China NMPA Product Recall - Combined compression interlocking intramedullary nail system for the hip (trade name: TriGen InterTAN)

On November 23, 2017, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Smith & Nephew, Inc. This action was based on a recall report submitted by the company on October 30, 2017. The recall affects the Combined Compression Interlocking Intramedullary Nail System for Hips, marketed under the trade name TriGen InterTAN (model 71675384, batch 16LM07111). The critical issue identified was a manufacturing error that resulted in the intramedullary nail being inserted upside down. This device is specifically designed for treating various severe femoral fractures, including comminuted, spiral, and segmental fractures. Smith & Nephew, Inc., through its agent Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., initiated this voluntary recall to address the defect. Although the product is globally distributed, the specific batch identified with this manufacturing anomaly had no sales in China, with affected units reportedly distributed in Germany and Italy. The Class III recall signifies a situation where use of or exposure to a violative product is not likely to cause adverse health consequences, but the company’s prompt action aims to prevent any potential risks to patient safety stemming from this manufacturing flaw.