China NMPA Product Recall - Hip Components - Bipolar Head

Zimmer Biomet (Shanghai) Medical International Trading Co., Ltd. initiated a voluntary Class II recall on September 8, 2020, for specific batches of its Hip Components (Bipolar Head). This action, reported under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a potential issue where the product's function could be compromised. The primary concern identified is that the affected components underwent two radiation sterilization cycles, which may impact their intended performance. As of the recall announcement, the company has not received any complaints directly related to this specific issue. The voluntary recall covers two designated batches of the hip components, identified by Registration Certificate No. 国械注进20153463783. Detailed information regarding the precise models, specifications, and batch numbers is available in the associated "Medical Device Recall Event Report Form." This proactive measure by Zimmer Biomet demonstrates the company's commitment to product safety and adherence to regulatory standards.