China NMPA Product Recall - Dental Implant Series Products

Nobocom Trading (Shanghai) Co., Ltd., the China-based responsible unit for manufacturer Nobel Biocare AB, initiated a voluntary Level III recall of various dental implant products. The recall, reported on September 14, 2015, and published by the National Medical Products Administration (NMPA) on October 13, 2015, was prompted by a printing error on the Chinese labels. Specifically, the expiration dates on the Chinese labels did not match those on the English labels. Despite the labeling inconsistency, investigations confirmed that all discrepancies fell within the products' verified expiration periods, ensuring no threat to patient safety. This meant the issue was primarily a labeling defect rather than a product integrity or efficacy concern. In response, Nobocom Trading implemented two key corrective actions. First, the company committed to sending notification letters to all customers who had received products from the identified affected batches. Second, for any unsold products remaining in inventory, the company pledged to assist in correcting the expiration dates on the Chinese labels to ensure accuracy and compliance. This swift action aimed to rectify the administrative error and maintain transparency with customers and the regulatory authority.