# China NMPA Product Recall - Dental machine root canal file Protaper Next

Source: https://www.globalkeysolutions.net/records/china_product_recall/maillefe-instruments-holding-sarl/12eddcea-9c1c-4485-be2a-82a6ab599804
Source feed: China

> China NMPA product recall for Dental machine root canal file Protaper Next by MAILLEFE INSTRUMENTS HOLDING SARL published June 11, 2025. Recall level: Level 3 Recall. MAILLEFER INSTRUMENTS HOLDING SARL has initiated a voluntary Class III recall of its Protaper Next d

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maiffer Instruments Holding SARL has initiated a voluntary recall of dental machine root canal files.
- Company Name: MAILLEFE INSTRUMENTS HOLDING SARL
- Publication Date: 2025-06-11
- Product Name: Dental machine root canal file Protaper Next
- Recall Level: Level 3 Recall
- Recall Reason: Some product blister packs have poor sealing issues (the U-shaped side of the blister pack is not sealed).
- Discovering Company: Dentsply Sirona Dental Products (Shanghai) Co., Ltd.
- Manufacturing Company: MAILLEFE INSTRUMENTS HOLDING SARL
- Summary: MAILLEFER INSTRUMENTS HOLDING SARL has initiated a voluntary Class III recall of its Protaper Next dental machine root canal files, as reported by Dentsply Sirona Dental Products (Shanghai) Co., Ltd. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical packaging defect where the U-shaped side of certain product blister packs was not properly sealed. This issue could compromise the sterility and integrity of the dental instruments, potentially impacting patient safety. The affected products, identified by National Medical Device Registration Certificate No. 20152171646, are currently not in stock, indicating a proactive measure to prevent their distribution to the market. The recall signifies adherence to the NMPA's regulatory framework for medical devices in China, where a Class III recall indicates a low likelihood of adverse health consequences. Detailed information concerning specific models, specifications, and batch numbers is available in the manufacturer's Medical Device Recall Event Report Form, ensuring a controlled management process for the impacted devices.

Company: https://www.globalkeysolutions.net/companies/maillefe-instruments-holding-sarl/6eb445fb-41b7-4a4c-af1b-3359a829d41a