# China NMPA Product Recall - Synthetic absorbable surgical sutures

Source: https://www.globalkeysolutions.net/records/china_product_recall/johnson-johnson-international-co-european-logistics-center/e478ff98-4ece-4e06-8801-640d993124cd/
Source feed: China

> China NMPA product recall for Synthetic absorbable surgical sutures by Johnson & Johnson International, c/o European Logistics Center published August 30, 2016. Recall level: Level III. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for sp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. voluntarily recalls synthetic absorbable surgical sutures.
- Company Name: Johnson & Johnson International, c/o European Logistics Center
- Publication Date: 2016-08-30
- Product Name: Synthetic absorbable surgical sutures
- Recall Level: Level III
- Recall Reason: This recall is due to human error by the original manufacturer, which resulted in the production date and product expiration date printed on the Chinese label of a specific batch of products not conforming to the requirements of the original manufacturer's procedural documents. In addition, due to the incorrect production date on the Chinese label, the registration certificate number signed at the time did not match the registration certificate number approved by the drug regulatory authority.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Johnson & Johnson International, c/o European Logistics Center
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall for specific batches of synthetic absorbable surgical sutures, as reported by the National Medical Products Administration (NMPA) on August 30, 2016. The recall, stemming from a June 2016 company report, addresses non-compliance with Chinese regulatory labeling requirements. The primary issues identified were discrepancies in the production and expiration dates on the Chinese labels, which did not conform to the original manufacturer's procedures, and an inconsistent registration certificate number compared to the officially approved record. This recall affects 974 boxes of products, specifically models W9560 and W9561, distributed throughout China. The company clarified that these labeling inconsistencies do not pose a direct safety or usage risk to patients but are being addressed to eliminate regulatory non-compliance. Corrective actions include notifying distributors and users to return all unused affected products that are still within their shelf life. These returned sutures will subsequently be destroyed locally, ensuring adherence to regulatory standards and accurate product information in the market.

Company: https://www.globalkeysolutions.net/companies/johnson-johnson-international-co-european-logistics-center/1ef45e4b-d2cd-4f02-a6cc-6272d0f5325b/