China NMPA Product Recall - Unicompartmental knee joint system components

The National Medical Products Administration (NMPA) published a recall notice (Index No. JGXX-2017-10406) on May 17, 2017, concerning unicompartment knee joint system components. The manufacturer, Biomet UK LTD., is voluntarily recalling the Oxford unicompartment knee joint non-cemented tibial type due to reports of tibial plateau fractures in patients. Zimmer Medical (Shanghai) International Medical Trading Co., Ltd., the distributor in China, reported this issue. A global complaint analysis revealed that 0.12% of patients experienced tibial plateau fractures. Investigations determined that while the product was manufactured to design specifications, adherence to specific surgical techniques outlined in the product's accompanying instructions is crucial to minimize this risk. As part of the voluntary recall and field safety notification measures, Biomet UK LTD. is emphasizing the critical importance of following applicable surgical techniques and the contents of the product instructions. The NMPA has requested all provincial, autonomous region, and municipal food and drug administration departments to enhance supervision and management of such medical devices. It is important to note that the manufacturer confirmed the recalled product was not sold in China, and no adverse events or related complaints were recorded domestically. The recall applies globally.