China NMPA Product Recall - Calcium sulfate artificial bone

Biocomposites Ltd. initiated a voluntary Class III recall of its calcium sulfate artificial bone products, registered under certificate number 20173466999. This action, publicly reported by the National Medical Products Administration (NMPA) on March 11, 2021, and communicated by Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., was prompted by identified packaging errors affecting specific models and batches of the artificial bone. The recall serves as a proactive measure by the manufacturer to address these critical packaging inconsistencies. The NMPA, responsible for regulatory oversight of medical devices, disseminated this recall notice to ensure awareness and facilitate appropriate actions throughout the healthcare supply chain. The affected product models, specifications, and batch numbers are detailed in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product quality and patient safety, addressing the issue in accordance with the NMPA's regulatory framework governing medical device distribution and use.