# China NMPA Product Recall - Polyester non-absorbable sutures

Source: https://www.keypedia.com/records/china_product_recall/thicon-llc/8b52846b-e24e-4fbf-8c1b-131a2dd9a169
Source feed: China

> China NMPA product recall for Polyester non-absorbable sutures by THICON, LLC published May 23, 2019. Recall level: Level 2 Recall. Ethicon, LLC, in conjunction with its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon, LLC voluntarily recalls non-absorbable polyester sutures.
- Company Name: THICON, LLC
- Publication Date: 2019-05-23
- Product Name: Polyester non-absorbable sutures
- Recall Level: Level 2 Recall
- Recall Reason: Ethicon discovered that one of the raw materials in non-absorbable polyester sutures may have a high endotoxin content.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: Ethicon, LLC, in conjunction with its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary Class II recall of specific batches of non-absorbable polyester sutures. This action, reported on May 13, 2019, and published by the National Medical Products Administration (NMPA) on May 23, 2019, was prompted by the discovery of a potentially high endotoxin content in the raw materials used to manufacture the affected products. These sutures, registered under certificate no. 20152652256, are indicated for general soft tissue grafting and ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. The recall affects specific models and batches, including X865W33, X425H, and PBQ797 (batch PBQ426), and impacts regions such as Australia, Canada, and the USA. The required action involves the voluntary recall of these identified products, with no additional corrective actions specified for units not imported into China.

Company: https://www.keypedia.com/companies/thicon-llc/1cf766f6-0a1e-45f9-94d7-03ceb0f19cb1