China NMPA Product Recall - Dental Implant

On February 28, 2022, the National Medical Products Administration (NMPA) publicly reported a Class II voluntary recall of certain dental implants manufactured by Nobel Biocare AB. This recall was initiated by the manufacturer and formally reported by Nobel Biocare Trading (Shanghai) Co., Ltd. The specific product affected is the Dental Implant, identified by National Medical Device Registration Certificate No. 20153170003. The primary reason for this corrective action was a critical quality deviation: the internal hexagons of a particular model and batch of these implants were found not to comply with established product specifications. This non-conformance represents a potential quality defect that could impact device performance or patient safety, necessitating the recall. Nobel Biocare AB's proactive voluntary recall demonstrates their commitment to addressing product deficiencies under the NMPA's regulatory guidance. Further comprehensive details concerning the exact models, specifications, and batch numbers of the affected dental implants are provided in the official "Medical Device Recall Event Report Form" attached to the NMPA's announcement. This incident highlights the robust regulatory framework in place to monitor and ensure the quality and safety of medical devices distributed within the region.