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

Source: https://www.keypedia.com/records/china_product_recall/thicon-llc/67816304-26fe-4b11-a66a-a411cd7f6234
Source feed: China

> China NMPA product recall for Absorbable sutures (product: VICRYL FLOS) by THICON, LLC published July 19, 2017. Recall level: Level 3. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of spe

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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: 2017-07-19
- 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. To date, there have been no related complaints or adverse event reports in China.
- 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 specific absorbable sutures (VICRYL PLUS) in China, as reported on July 19, 2017, to the National Medical Products Administration (NMPA). This action followed routine market supervision and spot checks, which identified that a batch of the sutures had a diameter slightly exceeding the registered product standard. While Johnson & Johnson confirmed that the products met their internal release standards and posed no reported risk to patient health or surgical outcomes, the recall was undertaken to ensure full compliance with Chinese medical device regulations. The affected products were identified under registration number CFDA (Imported) No. 20123654478 (Revised), with 242 boxes of model VCP311H, specification KBK922, distributed in China. Required actions included notifying all affected customers and obtaining confirmation of receipt. Additionally, all unused products were to be returned to Johnson & Johnson for controlled destruction. No complaints or adverse events related to this issue were reported in China at the time of the recall.

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