# China NMPA Product Recall - Absorbable sutures (product: VICRYL FLOS)

Source: https://www.globalkeysolutions.net/records/china_product_recall/thicon-llc/13dd516c-9844-44bd-82b5-d842ea17ea95/
Source feed: China

> China NMPA product recall for Absorbable sutures (product: VICRYL FLOS) by THICON, LLC published July 18, 2017. Recall level: Level 3. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls absorbable sutures
- Company Name: THICON, LLC
- Publication Date: 2017-07-18
- Product Name: Absorbable sutures (product: VICRYL FLOS)
- Recall Level: Level 3
- Recall Reason: The suture diameter of this batch was slightly coarser than the required diameter in the registered product standard during market sampling and testing. Ethicon confirms that the above products were tested and released according to Ethicon's standards, and this result will not affect surgical procedures or pose a risk to patient health or safety. To better comply with Chinese regulations, our company has decided to voluntarily withdraw the product.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its Absorbable Sutures (VICRYL PLUS), specifically model VCP311H/KBK922, affecting 242 boxes in China. The recall, reported on May 27, 2017, and published by the National Medical Products Administration (NMPA) on July 18, 2017, stemmed from market supervision and spot checks. These checks revealed that the suture diameter of the affected batch was slightly coarser than the registered product standards. While the manufacturer, Ethicon, confirmed that the products were released according to its standards and posed no risk to patient health or surgical procedures, and no adverse events or complaints were reported, the company decided to proceed with the recall to ensure full compliance with Chinese regulations. As part of the corrective actions, Johnson & Johnson required customers to be notified and provide confirmation receipts. Additionally, all unused affected products were to be returned to Johnson & Johnson for unified destruction. This proactive measure underlines the company's commitment to regulatory adherence in the Chinese market.

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