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

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/94a81407-d790-4793-b3de-31a2d0f0a6ee/
Source feed: China

> China NMPA product recall for Steel and nickel-titanium mechanical root canal instruments (Mani NRT Files) by Mani Co., Ltd./MANI, INC./Mani Co., Ltd. published June 22, 2021. Recall level: Level 3 Recall. MANI, INC., supported by MANI (Beijing) Trading Co., Ltd., has initiated a voluntary recall for spec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Mani, Inc. is voluntarily recalling its steel and nickel-titanium mechanical root canal instruments, Mani NRT Fine.
- Company Name: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Publication Date: 2021-06-22
- Product Name: Steel and nickel-titanium mechanical root canal instruments (Mani NRT Files)
- Recall Level: Level 3 Recall
- Recall Reason: Among the steel and nickel-titanium mechanical root canal instruments manufactured by Manny NRT File, which is classified as "electric dental file" in Japan, the product specification "NRT-GPR" is described as intended for use as an "electric dental spiral remover." However, using this specification of product as an "electric dental file" does not fully utilize the product's capabilities.
- Discovering Company: Mani (Beijing) Trading Co., Ltd.
- Manufacturing Company: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/mani-co-ltdmani-incmani-co-ltd/836ee1e7-74df-4528-b77f-fad49f45f55c/