China NMPA Product Recall - Unicompartmental knee joint system components

The National Medical Products Administration (NMPA) issued notice JGXX-2017-10410 concerning a global voluntary recall initiated by Biomet UK LTD. for its Oxford unicompartment knee joint uncemented tibial components (NMPA Registration Certificate No.: 20163462135). Zimmer Medical (Shanghai) International Medical Trading Co., Ltd. distributes these products in China. The primary issue identified is a 0.12% worldwide incidence of tibial plateau fractures in patients. Investigations determined that while the product's design met specifications, the fractures are attributed to the critical importance of surgical techniques and strict adherence to the product's accompanying instructions. Although the affected product batches were not sold in China and no domestic adverse events were reported, the NMPA requested all provincial Food and Drug Administrations to enhance supervision of similar medical devices. Biomet UK LTD. is implementing field safety notification measures to reinforce correct surgical procedures and proper use, thereby mitigating potential risks and ensuring patient safety.