# China NMPA Product Recall - Spinal surgery navigation and positioning system

Source: https://www.globalkeysolutions.net/records/china_product_recall/mazor-robotics-ltd/99905188-e0e2-4052-b9a0-5de1e5eb9759/
Source feed: China

> China NMPA product recall for Spinal surgery navigation and positioning system by Mazor Robotics Ltd. published November 01, 2023. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) issued notice JGXX-2023-10206 on November 1, 202

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Mazor Robotics Ltd. is voluntarily recalling its spinal surgery navigation and positioning system.
- Company Name: Mazor Robotics Ltd.
- Publication Date: 2023-11-01
- Product Name: Spinal surgery navigation and positioning system
- Recall Level: Level 2 Recall
- Recall Reason: Some products had incorrect screw packaging inside.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Mazor Robotics Ltd.
- Summary: The National Medical Products Administration (NMPA) issued notice JGXX-2023-10206 on November 1, 2023, announcing a voluntary Class II recall of the Spinal Surgery Navigation and Positioning System manufactured by Mazor Robotics Ltd. This action was reported by Medtronic (Shanghai) Management Co., Ltd. The primary reason for the recall, which pertains to products registered under certificate No. 20213010107, is the discovery of incorrect packaging of screws in certain units of the device. A Class II recall indicates that exposure to the affected product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. Mazor Robotics Ltd. is undertaking this recall to address the packaging discrepancy and ensure product safety. Detailed information concerning the specific affected product models, specifications, and batch numbers, along with required actions for stakeholders, is contained within the accompanying "Medical Device Recall Event Report Form." Parties in possession of these systems should consult the attachment for precise guidance on identifying and handling the recalled devices.

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