# 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/edd6c345-2b6a-4cfe-8b61-75f70eb4725d/
Source feed: China

> China NMPA product recall for Knee joint surgical instruments by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published December 20, 2019. Recall level: Level 3 Recall. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Cla

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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: 2019-12-20
- Product Name: Knee joint surgical instruments
- Recall Level: Level 3 Recall
- Recall Reason: The product in question has an out-of-tolerance spring locking pin hole size in the affected cutting module, which may cause the spring locking pin to loosen.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific knee surgical instruments, as reported by the National Medical Products Administration (NMPA) on December 20, 2019. The recall was prompted by a critical manufacturing defect: the spring locking pin hole in the affected cutting module exhibited out-of-tolerance dimensions. This dimensional inconsistency poses a risk of the spring locking pin loosening during use, which could potentially compromise the functionality of the instrument and impact surgical outcomes.

This voluntary action, overseen by the NMPA, demonstrates the company's commitment to addressing product quality concerns and maintaining patient safety. While the document does not detail specific inspection dates, the recall itself acts as a significant regulatory event stemming from a product quality issue. The company is responsible for retrieving all affected instruments from distribution. Comprehensive details regarding the specific models, specifications, and batch numbers of the recalled devices are provided in the accompanying "Medical Device Recall Event Report Form." This incident underscores the stringent quality control necessary in the medical device sector and the regulatory framework established by the NMPA to ensure product reliability and patient well-being.

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