# China NMPA Product Recall - Knee joint surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/a8852a61-7c76-4b8b-a878-66293e43697b/
Source feed: China

> China NMPA product recall for Knee joint surgical instruments by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published August 15, 2019. Recall level: Level 3 Recall. On August 15, 2019, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of knee surgical instruments.
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-08-15
- Product Name: Knee joint surgical instruments
- Recall Level: Level 3 Recall
- Recall Reason: The product in question suffers from manufacturing errors, with some parts of the tooling exceeding dimensional specifications, resulting in the guide being unable to be used with the knee joint space balancer handle.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: On August 15, 2019, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its knee joint surgical instruments. This action was taken due to a manufacturing error where the dimensions of a tool fitting part exceeded standard specifications. Consequently, the guide could not be properly used with the knee joint space balancer handle, impacting the instrument's intended function. The National Medical Products Administration (NMPA) in China oversees such regulatory actions. This recall falls under the NMPA's framework, which mandates manufacturers to address product deficiencies to ensure medical device safety and efficacy. While specific inspection dates were not provided, the recall announcement itself signifies the company's responsive action. The affected products were identified under Registration Certificate No.: 20151696. Smith & Nephew was required to execute this comprehensive Class III recall to remove the non-conforming instruments from the market, preventing potential procedural issues and upholding product reliability standards for medical use.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-medical-products-international-trading-shanghai-co-ltd/838e3e3f-d561-4f82-9b98-419473c58276/