# China NMPA Product Recall - Femoral stem system (trade name: SMF)

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-medical-products-international-trading-shanghai-co-ltd/b3a4e95c-68c6-4275-8f71-f1b342fa20fd/
Source feed: China

> China NMPA product recall for Femoral stem system (trade name: SMF) by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. published March 01, 2019. Recall level: Level 3 Recall. On March 1, 2019, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiat

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. is voluntarily recalling its femoral stem system (trade name: SMF).
- Company Name: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Publication Date: 2019-03-01
- Product Name: Femoral stem system (trade name: SMF)
- Recall Level: Level 3 Recall
- Recall Reason: Issues such as incorrect size labeling on product outer packaging
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Summary: On March 1, 2019, Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its Femoral Stem System, marketed under the trade name SMF. This action was taken due to a critical labeling issue where the product's outer packaging displayed incorrect size information. The National Medical Products Administration (NMPA) serves as the overarching regulatory body overseeing this process. The affected medical device, holding registration certificates from the Shanghai Food and Drug Administration and CFDA (Imported), is being recalled to ensure patient safety and product integrity. As part of the required actions, Smith & Nephew has committed to providing detailed information regarding the specific models, specifications, and batch numbers of the impacted products in a comprehensive 'Medical Device Recall Event Report Form.' This measure is crucial for healthcare providers and facilities to identify and remove the recalled devices from circulation effectively. The voluntary nature of the recall underscores the company's responsibility in addressing product discrepancies and adhering to regulatory standards set forth by the NMPA.

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