# China NMPA Product Recall - Steel plate screw tool system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/534a9a81-9582-42db-ad63-000270a28463/
Source feed: China

> China NMPA product recall for Steel plate screw tool system by Smith & Nephew Inc. published September 13, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) published a notice on September 13, 2017, concer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. proactively recalls its sheet screw tool systems.
- Company Name: Smith & Nephew Inc.
- Publication Date: 2017-09-13
- Product Name: Steel plate screw tool system
- Recall Level: Level 3 Recall
- Recall Reason: Due to a problem in the production process, the mounting holes for the screw removal device are missing, preventing the affected tools from connecting to the screws for insertion or removal.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: The National Medical Products Administration (NMPA) published a notice on September 13, 2017, concerning a voluntary Class III recall initiated by Smith & Nephew, Inc., for its Plate Screw Tool System. The recall stemmed from a manufacturing defect where the screw removal device lacked a crucial mounting slot, preventing the tool from connecting properly with screws for implantation or removal. This issue affected products with Registration No. 20161364 and model/specification 71177169 16FTMH054. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the agent in China, submitted the Medical Device Recall Event Report Form on August 7, 2017.

Under the NMPA's regulatory framework for medical device oversight, Smith & Nephew, Inc. voluntarily initiated this recall. While the Plate Screw Tool System is used in orthopedic surgery for bone plate and screw implantation, the report explicitly confirmed that this specific recall "does not affect China." No affected products were sold or distributed within the Chinese market. Therefore, although the company took corrective action by recalling the defective tools in other regions (e.g., Australia, Switzerland, Norway, Russia, Sweden), no specific actions were required for Chinese distributors or consumers.

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