# China NMPA Product Recall - Large Cannulated Screw System

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/17868ede-9678-4450-8520-a97e8839f20c/
Source feed: China

> China NMPA product recall for Large Cannulated Screw System by Smith & Nephew Inc. published October 15, 2021. Recall level: Level 2. Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary Class II recall of its La

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. is issuing a voluntary recall for its Large Cannulated Screw System.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2021-10-15
- Product Name: Large Cannulated Screw System
- Recall Level: Level 2
- Recall Reason: Due to issues involving specific models and batches of products, there are errors in product labeling information. For example, the label may indicate that the screw is fully threaded, but the actual product may only have partially threaded screws.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary Class II recall of its Large Cannulated Screw System, as announced on October 15, 2021. This action was taken due to a significant labeling discrepancy where the product label incorrectly stated the screws were fully threaded, while the actual devices were only partially threaded. The recall affects specific models and batches of the Large Cannulated Screw System (Registration Certificate No.: 20153133639). Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. reported this issue, leading to the manufacturer's voluntary recall. This regulatory action falls under the oversight of the National Medical Products Administration (NMPA) in China. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has voluntarily undertaken the necessary steps to address this issue. Further detailed information regarding the affected product models, specifications, and batches is available in the 'Medical Device Recall Event Report Form' provided by Smith & Nephew, Inc.

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