# China NMPA Product Recall - Knee joint surgical instruments

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-inc/cedfc4b0-904e-4ff1-8b1e-8061f64ae0ce/
Source feed: China

> China NMPA product recall for Knee joint surgical instruments by Smith & Nephew Inc. published October 31, 2018. Recall level: Level 3. Smith & Nephew, Inc. initiated a Class III voluntary recall of specific knee surgery instruments, as

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew, Inc. Activate Recall of Knee Surgery Instruments
- Company Name: Smith & Nephew Inc.
- Publication Date: 2018-10-31
- Product Name: Knee joint surgical instruments
- Recall Level: Level 3
- Recall Reason: The buckles of the affected batch of distal osteotomy modules are too thin, making it impossible for them to lock with the distal positioning guide plate.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Inc.
- Summary: Smith & Nephew, Inc. initiated a Class III voluntary recall of specific knee surgery instruments, as reported by the National Medical Products Administration (NMPA) on October 31, 2018. The recall, detailed in a report dated October 9, 2018, was prompted by a manufacturing defect in the distal osteotomy module. Specifically, the retaining ring of the affected products was found to be excessively thin, preventing it from securely locking with the distal positioning guide plate. This functional issue could potentially compromise the safety and efficacy of the instruments during knee replacement surgery. The affected product model is 71441147 DCF MIS Remote Osteotomy Module, with several identified batch numbers. While the recall was initiated by the manufacturer, Smith & Nephew, Inc., with its agent Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. involved in the reporting process, it is explicitly stated that this specific recall does not impact the market in China. The regulatory framework for this action falls under the NMPA's medical device oversight, with the product holding National Medical Device Filing No. 20151696. The required action is a voluntary recall in other regions, but no action is required in China for these specific batches.

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