# China NMPA Product Recall - Skin suture

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-endo-surgery-llc/7a6ab9bf-9860-4c48-8314-f81964fbc953/
Source feed: China

> China NMPA product recall for Skin suture by Ethicon Endo-Surgery, LLC published December 09, 2015. Recall level: Level III. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level III recall for sp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls skin suture devices.
- Company Name: Ethicon Endo-Surgery, LLC
- Publication Date: 2015-12-09
- Product Name: Skin suture
- Recall Level: Level III
- Recall Reason: Ten batches of products manufactured between December 14, 2014, and May 24, 2015, had their registration certificate numbers incorrectly printed on their Chinese labels as "国食药监械（进）字2011 2662297号" (National Food and Drug Administration Medical Device (Imported) No. 2011 2662297), while the correct registration certificate number is "国械注进20142665651". From May 25, 2015, the latest registration certificate number for these products is "国械注进20142655651".
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon Endo-Surgery, LLC
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level III recall for specific batches of its Skin Suture Devices. This action, reported on November 7, 2015, and published by the National Medical Products Administration (NMPA) on December 9, 2015, addressed a critical labeling error. Products manufactured between December 14, 2014, and May 24, 2015, were found to have a misprinted registration certificate number on their Chinese labels. The incorrect number displayed was “国食药监械（进）字2011 2662297” instead of the correct “国械注进20142665651”.

The recall affected 10 batches of PMW35 model skin suture devices, with approximately 14,321 units sold in China. While this mislabeling issue presented no direct risk to patient safety or product performance, the company proactively undertook the recall to mitigate potential regulatory compliance risks. The required actions included the immediate withdrawal of all unused affected products from the market. Furthermore, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. informed relevant distributors and users about the corrective measures, instructing them to return any remaining affected inventory. This ensures adherence to NMPA regulatory standards.

Company: https://www.globalkeysolutions.net/companies/ethicon-endo-surgery-llc/dfce5be3-6a9d-4239-8ba0-5d5283b81a02/