China NMPA Product Recall - Machine-operated root canal files and dental files

On January 20, 2022, the National Medical Products Administration (NMPA) published information regarding a voluntary Class III recall initiated by MAILLEFER INSTRUMENTS HOLDING S.A.R.L. This recall, reported by Dentsply Sirona Dental Products (Shanghai) Co., Ltd., involves micro-invasive root canal files and dental files. The core issue prompting this action is a product packaging sealing problem, which could potentially affect the integrity and sterility of these dental medical devices.

The recall encompasses various models, specifications, and batches of dental files and dental rigs, specifically those with registration certificate numbers 20182550087, 20192170561, and 20172067029. Under the NMPA's regulatory guidance, MAILLEFER INSTRUMENTS HOLDING S.A.R.L. is taking the necessary steps to remove these products from distribution. This required action aims to mitigate any potential risks to patient safety stemming from the packaging defect, ensuring compliance with medical device quality standards overseen by the NMPA.