# China NMPA Product Recall - Synthetic absorbable surgical sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/thicon-llc/9cac5af6-e11f-415a-9575-6e00594d0324/
Source feed: China

> China NMPA product recall for Synthetic absorbable surgical sutures by THICON, LLC published October 29, 2020. Recall level: Level 3 Recall. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., a subsidiary of Ethicon LLC, initiated a Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling synthetic absorbable surgical sutures.
- Company Name: THICON, LLC
- Publication Date: 2020-10-29
- Product Name: Synthetic absorbable surgical sutures
- Recall Level: Level 3 Recall
- Recall Reason: Due to an order system issue, the production date of a batch of synthetic absorbable surgical sutures, model J359H, batch number QCMDKS, does not match the medical device registration certificate.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., a subsidiary of Ethicon LLC, initiated a Class III voluntary recall of specific synthetic absorbable surgical sutures (model J359H, batch QCMDKS) on October 29, 2020. This action was reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall was prompted by an internal order system error, which resulted in a discrepancy between the product's manufacturing date and the date listed on its medical device registration certificate (No.: 20143655592).

Despite this administrative inconsistency, the company confirmed that the affected sutures were produced in adherence to all quality standards. The product's quality, performance, and safety remained unaffected, and no adverse events or patient injuries related to this issue have been reported. As a required action under the regulatory framework, Johnson & Johnson (Shanghai) proactively conducted the voluntary recall to rectify the labeling inaccuracy.

Further details concerning the affected models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form." This recall underscores a commitment to regulatory documentation compliance, even in situations where product efficacy and patient safety are not directly compromised.

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