China NMPA Product Recall - root canal retractor

MANI, INC., a manufacturer of dental instruments, initiated a voluntary Class III recall of its Root Canal Reamers (CFDA (Imported) No. 20112552313 (revised)) in China, as reported by its agent, MANI (Beijing) Trading Co., Ltd. The National Medical Products Administration (NMPA) publicly announced the recall on May 18, 2017. The core issue stemmed from incorrect label specifications; products with a true dimension of 25mm (#15-40) were mislabeled as 21mm (#15-40). This error affected batch R13K0773-00, produced on November 15, 2013, and other products manufactured between 2013 and 2014, with 1000 boxes distributed in China. The discrepancy was attributed to a manual data entry error during the labeling process. While the company assessed the risk of harm as low due to clinical verification practices, immediate corrective measures were implemented. MANI, INC. directed distributors to isolate and return all affected products for destruction. Furthermore, MANI (Beijing) Trading Co., Ltd. committed to informing customers via distributors about the labeling inaccuracy. To prevent recurrence, the company has transitioned to an automated barcode scanning system for label printing, eliminating manual data entry errors for future shipments to China.