China NMPA Product Recall - Implant base and screws

Nobel Biocare AB, through its subsidiary Nobel Biocare Trading (Shanghai) Co., Ltd., initiated a voluntary Class II recall of specific implant abutments and screws. This action was publicly announced by the National Medical Products Administration (NMPA) on June 12, 2019, following the manufacturer's identification of a potential labeling error. The affected products, bearing Registration Certificate No. 20163632245, are subject to this recall to address the identified discrepancy. A Class II recall, as designated by the NMPA, typically indicates a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. This proactive measure by Nobel Biocare AB highlights its commitment to product safety and regulatory compliance. Further comprehensive details regarding the specific models, specifications, and batch numbers of the recalled medical devices are accessible in the "Medical Device Recall Event Report Form" referenced in the NMPA's official notification. This event underscores the NMPA's role in overseeing medical product safety and the industry's responsibility in promptly addressing product-related concerns.