# China NMPA Product Recall - Spinal internal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-sofamor-danek-manufacturing/dfcb04bd-3005-475f-af83-88665964b03b
Source feed: China

> China NMPA product recall for Spinal internal fixation system by Medtronic Sofamor Danek Manufacturing published July 04, 2023. Recall level: Level 2 Recall. Medtronic Sofamor Danek Manufacturing, in collaboration with Medtronic (Shanghai) Management Co., Lt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Sofamor Danek Manufacturing initiates a recall of its spinal fixation system.
- Company Name: Medtronic Sofamor Danek Manufacturing
- Publication Date: 2023-07-04
- Product Name: Spinal internal fixation system
- Recall Level: Level 2 Recall
- Recall Reason: Incorrect materials used in accessories
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Sofamor Danek Manufacturing
- Summary: Medtronic Sofamor Danek Manufacturing, in collaboration with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class II recall of its spinal internal fixation system. This recall was reported by the National Medical Products Administration (NMPA) on July 4, 2023. The primary reason for this action is the use of incorrect materials in the manufacturing of the product's components. The NMPA's classification of this as a Class II recall signifies that the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The company is undertaking necessary steps to remove the impacted devices from circulation. Comprehensive details, including specific affected product models, specifications, and batch numbers, are provided in the "Medical Device Recall Event Report Form" submitted by Medtronic (Shanghai) Management Co., Ltd. This voluntary recall highlights the critical need for strict material control and quality assurance throughout the medical device manufacturing process to safeguard patient well-being and product performance.

Company: https://www.globalkeysolutions.net/companies/medtronic-sofamor-danek-manufacturing/810c5b35-c75a-4869-a0cc-eb80dc242d05