China NMPA Product Recall - Steel and nickel-titanium mechanical root canal instruments (Mani NRT Files)

MANI, INC., supported by MANI (Beijing) Trading Co., Ltd., has initiated a voluntary recall for specific steel and nickel-titanium mechanical root canal instruments, identified as MANI NRT Files. The recall specifically addresses the "NRT-GPR" specification, which is registered under Certificate No. 20152172611. The core concern is that while the "NRT-GPR" product is precisely engineered as an "electric dental spiral file," its broader application as a generic "electric dental file" may not fully realize its optimal functionality or potential. This implies a possible misalignment between the product's specialized design and its general use, which could affect performance. This recall, issued by the National Medical Products Administration (NMPA) on June 22, 2021, is a proactive measure by the manufacturer to uphold product standards. Inspection dates are not applicable to this voluntary recall notice. MANI, INC. is taking this action to ensure dental professionals use the instruments as intended. Comprehensive details on affected models, specifications, and batch numbers are provided in the accompanying "Medical Device Recall Event Report Form," guiding customers through the necessary steps.