# China NMPA Product Recall - Resin adhesive kit

Source: https://www.globalkeysolutions.net/records/china_product_recall/ivoire-wivadent-shanghai-trading-co-ltd/8e556a3c-1b00-4100-a353-8314c8ac1b62/
Source feed: China

> China NMPA product recall for Resin adhesive kit by Ivoire Wivadent (Shanghai) Trading Co., Ltd. published January 26, 2021. Recall level: Level 3. Ivocarb Vivadent (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its resin ad

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ivoire Wivadent (Shanghai) Trading Co., Ltd. is voluntarily recalling resin adhesive kits.
- Company Name: Ivoire Wivadent (Shanghai) Trading Co., Ltd.
- Publication Date: 2021-01-26
- Product Name: Resin adhesive kit
- Recall Level: Level 3
- Recall Reason: Packaging information does not match the actual product information
- Discovering Company: Ivoire Vardent (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Ivoire Wivadent (Shanghai) Trading Co., Ltd.
- Summary: Ivocarb Vivadent (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its resin adhesive kits (Registration Certificate No.: 20163632705). This recall, publicly reported on January 26, 2021, stems from critical discrepancies identified between the product's packaging information and its actual contents. The company's proactive measure was announced through the Shanghai Municipal Drug Administration website and subsequently indexed by the National Medical Products Administration (NMPA).
The core issue involves an inconsistency that could potentially impact user safety or product efficacy, necessitating the removal of affected batches from the market. While specific inspection dates are not detailed in the provided document, the recall notification itself signifies a regulatory action triggered by identified product non-conformity. The regulatory framework governing this recall involves both the local Shanghai Municipal Drug Administration and the national NMPA, highlighting a coordinated oversight of medical device safety. The required action for Ivocarb Vivadent is to execute this Class III recall, ensuring all affected resin adhesive kits are retrieved. Further details regarding specific models, specifications, and batch numbers are referenced in an attached "Medical Device Recall Event Report Form," indicating a structured approach to managing the product retrieval process. This event underscores the importance of accurate product labeling and consistent adherence to regulatory standards for medical devices within China.

Company: https://www.globalkeysolutions.net/companies/ivoire-wivadent-shanghai-trading-co-ltd/cee48079-f805-4c8b-989a-cb331bc6db90/