# China NMPA Product Recall - Dental thermal coagulation apparatus; Dental thermal coagulation apparatus Element Obturation Unit

Source: https://www.globalkeysolutions.net/records/china_product_recall/kava-shengbang-shanghai-dental-medical-devices-co-ltd/218f6fd8-a6e7-4994-af79-605bedc5d058/
Source feed: China

> China NMPA product recall for Dental thermal coagulation apparatus; Dental thermal coagulation apparatus Element Obturation Unit by Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd. published May 06, 2020. Recall level: Level 2. KaVo (Shanghai) Dental Medical Devices Co., Ltd. initiated a voluntary Class II recall of its dental

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd. is voluntarily recalling dental thermocoagulation devices (Element Obturation Units).
- Company Name: Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd.
- Publication Date: 2020-05-06
- Product Name: Dental thermal coagulation apparatus; Dental thermal coagulation apparatus Element Obturation Unit
- Recall Level: Level 2
- Recall Reason: During use, the curved root canal filling instrument (i.e., the working tip) may overheat during dental thermocoagulation.
- Discovering Company: Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd.
- Manufacturing Company: Kava Shengbang (Shanghai) Dental Medical Devices Co., Ltd.
- Summary: KaVo (Shanghai) Dental Medical Devices Co., Ltd. initiated a voluntary Class II recall of its dental thermocoagulation units, specifically Element Obturation Units. This significant regulatory action was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration on May 6, 2020. The primary issue prompting the recall is the potential for the curved root canal filling instrument, or working tip, to overheat during use, posing a direct safety risk to patients. This defect necessitates immediate corrective action to prevent adverse events. Operating under the regulatory framework of the NMPA, KaVo Shengbang is undertaking this recall as a required action to address the identified product non-conformity. The specific models, specifications, and batch numbers of the affected devices are detailed in the associated "Medical Device Recall Event Report Form," which is crucial for identifying and removing the hazardous units from circulation. This voluntary recall emphasizes the company's commitment to patient safety and adherence to strict medical device standards, ensuring that potentially unsafe products are swiftly withdrawn from the market.

Company: https://www.globalkeysolutions.net/companies/kava-shengbang-shanghai-dental-medical-devices-co-ltd/8e4e0d41-f358-42b3-97e3-621ac3e02360/