# China NMPA Product Recall - Artificial cervical intervertebral disc (trade name: Mobi-C)

Source: https://www.globalkeysolutions.net/records/china_product_recall/zimmer-medical-shanghai-international-trading-co-ltd/efd04999-eb89-4a5f-989a-29e8cd533a87/
Source feed: China

> China NMPA product recall for Artificial cervical intervertebral disc (trade name: Mobi-C) by Zimmer Medical (Shanghai) International Trading Co., Ltd. published January 11, 2019. Recall level: Level 2 Recall. Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Zimmer Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling artificial cervical intervertebral discs (trade name: Mobi-C).
- Company Name: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Publication Date: 2019-01-11
- Product Name: Artificial cervical intervertebral disc (trade name: Mobi-C)
- Recall Level: Level 2 Recall
- Recall Reason: Issues such as incorrect height listed on the inner label
- Discovering Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Zimmer Medical (Shanghai) International Trading Co., Ltd.
- Summary: Zimmer Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Artificial Cervical Intervertebral Disc, marketed under the trade name Mobi-C. Announced on January 11, 2019, this action was taken due to a significant labeling error: the product's height was incorrectly specified on its label. This recall pertains to devices with Registration Certificate No.: NMPA Medical Device (Imported) 2013 No. 3463751 (Revised). The company reported this issue and executed the recall under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, which initially issued the medical device registration certificate. Detailed information regarding the specific models, specifications, and affected batches is available in the "Medical Device Recall Event Report Form" attachment. This proactive measure by Zimmer Medical aims to address the labeling discrepancy and ensure the accurate identification and use of its medical devices, maintaining compliance with established regulatory standards for medical device labeling and safety.

Company: https://www.globalkeysolutions.net/companies/zimmer-medical-shanghai-international-trading-co-ltd/22d50256-8f36-4c1a-ba7d-ae035c933119/