# China NMPA Product Recall - Synthetic Absorbable Surgical Suture PDS* II (Polydioxanone) Monofilament

Source: https://www.globalkeysolutions.net/records/china_product_recall/thicon-llc/8ca4972a-0a3d-4a38-8006-7c2e4547672c/
Source feed: China

> China NMPA product recall for Synthetic Absorbable Surgical Suture PDS* II (Polydioxanone) Monofilament by THICON, LLC published August 10, 2023. Recall level: Level 2 Recall. Ethicon LLC, a medical device manufacturer, has initiated a voluntary Level II recall of specific mo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon LLC is voluntarily recalling its synthetic absorbable surgical suture, PDS* II (Polydioxanone) Monofilament.
- Company Name: THICON, LLC
- Publication Date: 2023-08-10
- Product Name: Synthetic Absorbable Surgical Suture PDS* II (Polydioxanone) Monofilament
- Recall Level: Level 2 Recall
- Recall Reason: Problem of reduced tensile strength
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: Ethicon LLC, a medical device manufacturer, has initiated a voluntary Level II recall of specific models and batches of its PDS* II (Polydioxanone) Monofilament Synthetic Absorbable Sutures. This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., was triggered by a detected decrease in the tensile strength of these sutures, which could potentially compromise their performance and safety during surgical applications. The recall is overseen by the National Medical Products Administration (NMPA), the primary regulatory body in China for medical devices. The official recall notification was published on August 10, 2023. While the document does not specify particular inspection dates, Ethicon LLC has proactively undertaken this recall to address the identified quality defect. The required action involves the comprehensive retrieval of all affected products from the market to prevent potential patient risks. Detailed information concerning the affected product models, specifications, and batch numbers is provided in the accompanying "Medical Device Recall Event Report Form" for stakeholders.

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