# China NMPA Product Recall - Total knee system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/c1d6dc32-1eee-4d21-a0da-e66160b00689/
Source feed: China

> China NMPA product recall for Total knee system by Smith & Nephew Inc. published October 23, 2023. Recall level: Level 2 Recall. Smith & Nephew, Inc. has initiated a voluntary Class II recall of its Total Knee Joint System (regis

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc., Inc., is issuing a voluntary recall of its total knee system.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2023-10-23
- Product Name: Total knee system
- Recall Level: Level 2 Recall
- Recall Reason: Some products were packaged incorrectly.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc. has initiated a voluntary Class II recall of its Total Knee Joint System (registration number 20183130286) due to identified packaging errors affecting certain products. This action was reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. and is overseen by the National Medical Products Administration (NMPA) of China. The recall, publicly announced on October 23, 2023, addresses critical quality control issues related to product packaging, which could potentially impact product integrity or proper identification.

While specific inspection dates are not provided within the document, the voluntary recall itself serves as a corrective measure under the NMPA's regulatory oversight for medical devices. The primary issue is the packaging anomaly, prompting the manufacturer to take proactive steps to retrieve affected units from the market. Companies operating within China's medical device sector are mandated to adhere to NMPA regulations, which include reporting adverse events and initiating recalls when product deficiencies are discovered.

As part of the required actions, Smith & Nephew has prepared a "Medical Device Recall Event Report Form." This crucial document details the specific models, specifications, and batch numbers of the affected Total Knee Joint Systems, enabling healthcare providers and distributors to identify and remove the recalled products effectively. This ensures patient safety and maintains compliance with the rigorous standards set by the NMPA for medical device distribution and use in China. The voluntary nature and Class II classification indicate a situation with a remote probability of serious adverse health consequences.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-inc/feb94bf5-8eb9-4a12-b2f7-02767ea39056/