# China NMPA Product Recall - Hinged knee joint system

Source: https://www.globalkeysolutions.net/records/china_product_recall/smith-nephew-orthopedics-ltd/415341cd-61f2-4cf2-a697-6dbd66a51dae/
Source feed: China

> China NMPA product recall for Hinged knee joint system by Smith & Nephew Orthopedics Ltd. published October 17, 2019. Recall level: Level 3. Smith & Nephew Orthopaedics AG. initiated a voluntary Class III recall of its Hinge Knee System, as 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Smith & Nephew Orthopaedics AG. Active recall for hinged knee systems
- Company Name: Smith & Nephew Orthopedics Ltd.
- Publication Date: 2019-10-17
- Product Name: Hinged knee joint system
- Recall Level: Level 3
- Recall Reason: The issue involves a manufacturing error in the product, where the pre-installed screws of the repair pad may not be able to assemble with the femoral component.
- Discovering Company: Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Smith & Nephew Orthopedics Ltd.
- Summary: Smith & Nephew Orthopaedics AG. initiated a voluntary Class III recall of its Hinge Knee System, as reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The National Medical Products Administration (NMPA) published this notification on October 17, 2019. The recall stems from a manufacturing error discovered in the pre-installed screws of the repair pad. This defect prevents proper assembly with the femoral component of the knee system, posing a potential issue for product functionality and patient safety.
The affected product is identified by Registration Certificate No.: 20153132089. While specific inspection dates are not detailed in this announcement, the report highlights the company's proactive measure in addressing the quality concern. The regulatory framework for this action falls under the NMPA, which is responsible for overseeing medical device safety and compliance in China.
As a required action, Smith & Nephew Orthopaedics AG. has issued a voluntary recall. Detailed information concerning the specific models, specifications, and batch numbers of the affected devices is available in the 'Medical Device Notification Form' and 'Medical Device Recall Event Report Form' attachments referenced in the NMPA's announcement. This recall underscores the importance of stringent manufacturing quality control to ensure medical device integrity and patient well-being.

Company: https://www.globalkeysolutions.net/companies/smith-nephew-orthopedics-ltd/ce4ad0e9-49c1-433f-b695-a82625bda19a/