China NMPA Product Recall - root canal retractor

The National Medical Products Administration (NMPA) announced on May 18, 2017, a voluntary Class III recall initiated by MANI, INC. for specific batches of its Root Canal Reamers. The recall, managed in China by MANI (Beijing) Trading Co., Ltd., addresses a critical labeling error on products manufactured between 2013 and 2014. The primary issue stemmed from incorrect label specifications, where products designed as 25mm length, sizes #15-40, were mistakenly labeled as 21mm length, sizes #15-40. This discrepancy was attributed to a manual data entry error during the labeling process. Approximately 1000 boxes, each containing six vials, were affected and sold within China under the registration number CFDA (Imported) No. 20112552313 (revised). Despite the labeling error, the potential for patient harm was assessed as relatively small, given that packaging is typically discarded post-sterilization and the length of a root canal reamer has minimal impact on clinical outcomes. In response, MANI, INC. is implementing corrective actions, including isolating and returning all affected products held in distributor stock for destruction. For products already shipped to customers, the company will issue notification letters through its distributors. Additionally, MANI, INC. has transitioned to an automatic barcode scanning system for products exported to China, aiming to prevent future manual data entry errors and enhance labeling accuracy.