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

Smith & Nephew, Inc., an international medical device manufacturer, initiated a voluntary Class III recall of its Combined Compression Interlocking Intramedullary Nail System for Hips, marketed as TriGen InterTAN (Registration Certificate No.: "国械注进20143465639"). The recall was formally reported to the National Medical Products Administration (NMPA) by its subsidiary, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., on October 30, 2017, with public notification on November 24, 2017. The critical issue identified was a manufacturing error resulting in the intramedullary nail being inserted upside down. This defect specifically impacts product model 71675384, TriGen InterTAN 10S (10mm x 18cm, 130°), from batch number 16LM07111. While the product is intended for various femoral fractures, sales of the affected batch were noted in Germany and Italy, with no reported sales in China. Under the NMPA's regulatory framework for medical devices, the company’s agent provided a formal Medical Device Recall Event Report. The required action involved the execution of a voluntary Class III recall, signifying that the product is unlikely to cause adverse health consequences, and demonstrated the company's commitment to addressing product quality concerns through corrective measures.