# China NMPA Product Recall - NYLON sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-inc-mani-inc/f93fe89e-6493-4fe0-9b2a-87563deacee7/
Source feed: China

> China NMPA product recall for NYLON sutures by MANI, INC. (MANI, INC.) published June 22, 2021. Recall level: Level 3 Recall. MANI, INC., through its subsidiary MANI (Beijing) Trading Co., Ltd., has initiated a voluntary Class

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MANI, INC., Inc. is voluntarily recalling its nylon sutures, MANI SUTURES NYLON.
- Company Name: MANI, INC. (MANI, INC.)
- Publication Date: 2021-06-22
- Product Name: NYLON sutures
- Recall Level: Level 3 Recall
- Recall Reason: There is an issue with the lack of detailed information about the adhesives in the listing documents in Japan.
- Discovering Company: Mani (Beijing) Trading Co., Ltd.
- Manufacturing Company: MANI, INC. (MANI, INC.)
- Summary: MANI, INC., through its subsidiary MANI (Beijing) Trading Co., Ltd., has initiated a voluntary Class III recall of specific models and batches of its MANI SUTURES NYLON (Registration Certificate No.: 20172650380). This action, overseen by the National Medical Products Administration (NMPA) and published on June 22, 2021, addresses a documentation issue rather than a direct product defect. The main violation cited is a lack of detailed information concerning the adhesive used, which was not adequately specified in the Japanese listing documents for the affected products. As a Class III recall, this indicates that the use of or exposure to the product is not likely to cause adverse health consequences. The required actions involve identifying and managing the specific affected product models and batches, as detailed in the accompanying "Medical Device Recall Table" and "Medical Device Recall Event Report Form," to ensure regulatory compliance and transparency in medical device information.

Company: https://www.globalkeysolutions.net/companies/mani-inc-mani-inc/94b2dbe0-6a45-4eb9-b823-0380aff91acb/