China NMPA Product Recall - Total knee replacement system

On March 26, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by DePuy (Ireland), a manufacturer of medical devices. The recall was reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The affected product is DePuy's Total Knee Replacement System (Registration Certificate No.: 20163460679). The primary reason for this recall is the discovery of potential packaging damage in specific models and batches of the total knee replacement systems. This issue raised concerns regarding the integrity of the product's sterile packaging, which could potentially compromise product safety or efficacy if used. As a Class II recall, the NMPA indicates that there is a possibility of temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company has taken proactive steps to address this issue by identifying and recalling the implicated products from the market. Further detailed information concerning the exact models, specifications, and batch numbers affected by this recall is available in the attached "Medical Device Recall Event Report Form" provided by the NMPA.