# China NMPA Product Recall - Dental treatment unit (INTEGO, INTEGO pro)

Source: https://www.globalkeysolutions.net/records/china_product_recall/sirona-dental-systems-gmbh/6bace0ca-9a98-404e-8e1b-cae65c70fbe7/
Source feed: China

> China NMPA product recall for Dental treatment unit (INTEGO, INTEGO pro) by Sirona Dental Systems GmbH published April 02, 2021. Recall level: Level III. Dentsply Sirona Dental Products (Shanghai) Co., Ltd., acting on behalf of Sirona Dental Systems GmbH

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dentsply Sirona Dental Products (Shanghai) Co., Ltd. is voluntarily recalling dental treatment units.
- Company Name: Sirona Dental Systems GmbH
- Publication Date: 2021-04-02
- Product Name: Dental treatment unit (INTEGO, INTEGO pro)
- Recall Level: Level III
- Recall Reason: The ability of seats to support accessories may weaken with age.
- Discovering Company: Dentsply Sirona Dental Products (Shanghai) Co., Ltd.
- Manufacturing Company: Sirona Dental Systems GmbH
- Summary: Dentsply Sirona Dental Products (Shanghai) Co., Ltd., acting on behalf of Sirona Dental Systems GmbH, has initiated a voluntary Class III recall for the seat support adapters used in its dental integrated treatment units. The affected products include the INTEGO and INTEGO pro models, registered under NMPA Registration No. 20152173894. This preventative measure addresses a potential age-related weakening in the function of these seat support adapters. The recall was reported to the National Medical Products Administration (NMPA) and publicized by the Shanghai Municipal Drug Administration. The official publication date of this recall event was April 2, 2021. The company is taking this proactive step to ensure ongoing product reliability and patient safety. Further specific details regarding affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/sirona-dental-systems-gmbh/880dd7ff-09c6-450d-bd6a-bd625e8660db/