# China NMPA Product Recall - Tungsten steel burs

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/60a4fbf9-f904-472c-91a6-b42b7c87ff16/
Source feed: China

> China NMPA product recall for Tungsten steel burs by Mani Co., Ltd./MANI, INC./Mani Co., Ltd. published August 02, 2016. Recall level: Level 3 Recall. Mani, Inc. (Japan), in conjunction with its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., in

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MANI, INC. is voluntarily recalling tungsten carbide sewing needles.
- Company Name: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Publication Date: 2016-08-02
- Product Name: Tungsten steel burs
- Recall Level: Level 3 Recall
- Recall Reason: During its self-inspection, Mani (Beijing) Trading Co., Ltd. discovered that for tungsten carbide needles shipped to China by Mani Co., Ltd. of Japan, after obtaining a change in the agent's address registration information on March 30, 2015, the company's label approval process and production preparation caused delays in updating the old and new labels. As a result, the products continued to use the old labels after March 30, 2015, and the production date and expiration date were not indicated on the Chinese labels of the products. In addition, the agent's address on the labels was not updated in a timely manner during the production period from March 30, 2015 to December 21, 2015.
- Discovering Company: Mani (Beijing) Trading Co., Ltd.
- Manufacturing Company: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Summary: Mani, Inc. (Japan), in conjunction with its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., initiated a voluntary Class III recall on August 2, 2016, for 104,843 boxes of Tungsten Carbide Needles (CFDA (Imported) No. 20132550769). This action followed a self-inspection revealing labeling non-conformities for products produced between March 30, 2015, and December 21, 2015.
The main issues involved the continued use of outdated labels after a registered agent's address change on March 30, 2015, and a failure to clearly indicate the production and expiration dates on Chinese labels. Additionally, the agent's updated address was not timely reflected on product packaging during the specified production period. These practices violate the National Medical Products Administration's "Regulations on the Management of Medical Device Instructions and Labels" (Order No. 6) and related SFDA notices concerning medical device registration and labeling.
Required actions include freezing shipments of non-compliant products, ensuring all future exports to China bear updated labels in accordance with current regulations, isolating and relabeling existing agent inventory, and issuing notification letters to affected customers. Mani, Inc. emphasized that despite the labeling errors, the product's 15-year shelf life prevents any adverse impact on its normal use.

Company: https://www.globalkeysolutions.net/companies/mani-co-ltdmani-incmani-co-ltd/836ee1e7-74df-4528-b77f-fad49f45f55c/