China NMPA Product Recall - root canal retractor

MANI, INC., an overseas manufacturer, and its agent, MANI (Beijing) Trading Co., Ltd., initiated a voluntary Class III recall of Root Canal Reamers in China, as reported to the National Medical Products Administration (NMPA) in May 2017. The recall specifically targets products with registration number CFDA (Imported) No. 20112552313 (Revised), including batch number R13K0773-00, produced on November 15, 2013. The core issue stemmed from incorrect label specifications due to a manual data entry error. Products that were actually 25mm in length were mistakenly labeled as 21mm. This discrepancy affected batches manufactured between 2013 and 2014.

While the potential for harm from this labeling error was assessed as relatively low, given that dental professionals typically verify product specifications during clinical use, MANI, INC. implemented several corrective actions. These actions included the isolation and return of affected products from distributors for destruction. Furthermore, the company committed to notifying all customers who had received affected products through their respective distributors. To prevent recurrence, MANI, INC. has since adopted an automatic label printing process via barcode scanning for products exported to China, thereby eliminating manual data entry and associated errors. This proactive measure ensures enhanced accuracy and patient safety.