# China NMPA Product Recall - Navigation surgical tools

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-navigation-inc/2a95e9c0-2fd8-4ac4-8122-7dac1980729c/
Source feed: China

> China NMPA product recall for Navigation surgical tools by Medtronic Navigation Inc. published October 17, 2019. Recall level: Level 2 Recall. On October 17, 2019, the National Medical Products Administration (NMPA) published details regarding

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Navigation, Inc. initiates voluntary recall of navigation surgical tools.
- Company Name: Medtronic Navigation Inc.
- Publication Date: 2019-10-17
- Product Name: Navigation surgical tools
- Recall Level: Level 2 Recall
- Recall Reason: The product in question has an assembly error, which may affect the accuracy of the navigation device.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Navigation Inc.
- Summary: On October 17, 2019, the National Medical Products Administration (NMPA) published details regarding a Class II voluntary recall initiated by Medtronic Navigation, Inc. This recall, reported by Medtronic (Shanghai) Management Co., Ltd., specifically targets certain navigation surgical tools. The underlying issue prompting this action is an identified assembly error within the devices. This flaw carries the significant potential to impair the accuracy of these crucial surgical tools, which could subsequently impact patient safety and the overall efficacy of medical procedures. Operating within the NMPA's regulatory framework, Medtronic Navigation, Inc. took this required measure to address the product quality concern proactively. The decision to implement a voluntary recall underscores the company's commitment to upholding high standards for product reliability and patient well-being. Detailed information, including the specific models, specifications, and batch numbers of the affected products, is thoroughly documented in the accompanying "Medical Device Recall Event Report Form." This decisive action by Medtronic ensures that potential risks associated with the use of the impacted surgical tools are effectively managed and mitigated.

Company: https://www.globalkeysolutions.net/companies/medtronic-navigation-inc/314c41df-1248-4c0a-88d1-30388476ffd7/