China NMPA Product Recall - Knee joint surgical tools

Biomet UK Limited, a manufacturer of knee surgery tools, initiated a voluntary Class II recall of specific batches of its surgical instruments. The recall was reported by its agent, Zimmer Medical (Shanghai) International Trading Co., Ltd., under the oversight of China's National Medical Products Administration (NMPA). The core issue identified was the use of incorrect raw materials in the manufacturing of the screw assembly, creating a potential risk of corrosion in the devices. This recall, formally reported on April 24, 2018, and published by the NMPA on May 7, 2019, pertains to knee surgery tools holding Registration Certificate No. 20160498. Although reported to Chinese authorities, the affected batches were not sold in China. Instead, the recall primarily impacts regions including the USA, Canada, Australia, Japan, and the European Union, where the company is taking corrective action by voluntarily removing the affected products from the market.