# China NMPA Product Recall - Spinal internal fixation system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-sofamor-danek-usa-inc/f4efe638-05a9-41ae-b964-109c6d1bec0f/
Source feed: China

> China NMPA product recall for Spinal internal fixation system by Medtronic Sofamor Danek USA, Inc. published October 22, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) issued a Level III voluntary recall notification

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Sofamor Danek USA, Inc. Active Recall of Spinal Internal Fixation Systems
- Company Name: Medtronic Sofamor Danek USA, Inc.
- Publication Date: 2018-10-22
- Product Name: Spinal internal fixation system
- Recall Level: Level 3 Recall
- Recall Reason: Our company received feedback from a customer that the packaging of the 5.0X45 universal screw, model 55840005045 batch 0648247W, is marked as "5.0mm X 45mm", but the laser markings on both sides of the screw head are "5.5 X 45".
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Sofamor Danek USA, Inc.
- Summary: The National Medical Products Administration (NMPA) issued a Level III voluntary recall notification (Index No. JGXX-2018-11239) on October 22, 2018, regarding a spinal internal fixation system. The recall was initiated by Medtronic Sofamor Danek USA, Inc., with Medtronic (Shanghai) Management Co., Ltd. reporting the issue on September 11, 2018. The primary concern was a labeling discrepancy for a specific 5.0x45 universal screw (Model 55840005045, Batch 0648247W). The product's packaging indicated "5.0mm X 45mm," while the laser marking directly on the screw head displayed "5.5 X 45," representing a potential for product misidentification. This recall was categorized as Class III due to the nature of the issue. Importantly, the affected products were exclusively designated for sale in the United States and were not distributed within China. As a result, Medtronic (Shanghai) Management Co., Ltd. confirmed that no corrective actions or further measures were necessary in China, as no recalled inventory entered the Chinese market.

Company: https://www.globalkeysolutions.net/companies/medtronic-sofamor-danek-usa-inc/3dae4c6c-7556-4da9-a13d-28702559ac2b/