# China NMPA Product Recall - MONOCRYL (Poliglecaprone 25) Monofilament Synthetic Absorbable Suture

Source: https://www.globalkeysolutions.net/records/china_product_recall/thicon-llc/c3803ac4-d4e5-443e-8702-752e4da015aa/
Source feed: China

> China NMPA product recall for MONOCRYL (Poliglecaprone 25) Monofilament Synthetic Absorbable Suture by THICON, LLC published October 18, 2024. Recall level: Level 2 Recall. On October 18, 2024, Ethicon LLC, a prominent medical device manufacturer, initiated a voluntary Cla

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon LLC is voluntarily recalling synthetic absorbable surgical sutures.
- Company Name: THICON, LLC
- Publication Date: 2024-10-18
- Product Name: MONOCRYL (Poliglecaprone 25) Monofilament Synthetic Absorbable Suture
- Recall Level: Level 2 Recall
- Recall Reason: Material confusion resulted in some packages containing the wrong needle type and thread specification.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: THICON, LLC
- Summary: On October 18, 2024, Ethicon LLC, a prominent medical device manufacturer, initiated a voluntary Class II recall of its MONOCRYL (Poliglecaprone 25) Monofilament Synthetic Absorbable Suture. This action, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., addresses a critical issue of material confusion, where certain product packages were found to contain incorrect needle models and suture specifications. Such discrepancies could potentially lead to the use of an unsuitable device during surgical procedures, posing risks to patient safety and efficacy. The affected products are specifically the 1% synthetic absorbable surgical sutures, which are registered under National Medical Device Registration Certificate 20193022157. The recall is being managed under the regulatory oversight of China's National Medical Products Administration (NMPA) and pertains to products manufactured within China. Ethicon LLC has undertaken this voluntary measure to rectify the packaging errors and uphold product integrity. Comprehensive information detailing the specific models, specifications, and batch numbers involved in this recall is provided within the "Medical Device Recall Event Report Form," which serves as the official documentation for this corrective action. This ensures transparency and allows healthcare providers to identify and remove affected products from circulation.

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