# China NMPA Product Recall - Spine Surgical Navigation and Positioning System

Source: https://www.globalkeysolutions.net/records/china_product_recall/mazor-robotics-ltd/34707f9b-02dc-45db-92e5-b428563e5b9e/
Source feed: China

> China NMPA product recall for Spine Surgical Navigation and Positioning System by Mazor Robotics Ltd. published February 02, 2026. Recall level: Level 2 Recall. Mazor Robotics Ltd., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Mazor Robotics Ltd. is proactively recalling its Spine Surgical Navigation and Positioning System.
- Company Name: Mazor Robotics Ltd.
- Publication Date: 2026-02-02
- Product Name: Spine Surgical Navigation and Positioning System
- Recall Level: Level 2 Recall
- Recall Reason: Two software anomalies in software version 5.1.1 may cause a delay in real-time screen display or inconsistencies between the screw information displayed in the navigation and the screw information shown on the screen.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Mazor Robotics Ltd.
- Summary: Mazor Robotics Ltd., in conjunction with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Level II recall of its Spine Surgical Navigation and Positioning System. This action, reported by Medtronic (Shanghai) on February 2, 2026, addresses critical software anomalies identified in version 5.1.1 of the device. The primary issues involve potential delays in the real-time screen display during surgical navigation and inconsistencies between the screw information presented on the screen and the actual screw data. These software malfunctions could compromise the precision and safety of spinal surgical procedures. Operating under the oversight of the National Medical Products Administration (NMPA) and in adherence to medical device regulations, including the National Medical Device Registration Certificate No. 20213010, Mazor Robotics Ltd. is taking proactive steps to mitigate risks to patient safety. The recall encompasses specific models, specifications, and batches of the affected product, with detailed information available in the "Medical Device Recall Event Report Form." This required action underscores the commitment to device integrity and patient well-being, necessitating the removal of affected systems from the market to prevent potential adverse events.

Company: https://www.globalkeysolutions.net/companies/mazor-robotics-ltd/c62a50ec-62c3-49bf-bfaa-084f8d8eddee/