# China NMPA Product Recall - occipital-cervical-thoracic fusion system

Source: https://www.keypedia.com/records/china_product_recall/aesculap-ag/e15f3ddf-ccc0-441d-93e2-d5b7b8f2b1b5
Source feed: China

> China NMPA product recall for occipital-cervical-thoracic fusion system by Aesculap AG published July 13, 2020. Recall level: Level 2 Recall. B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: B. Braun Medical (Shanghai) International Trading Co., Ltd. is voluntarily recalling its cervicothoracic fusion system (trade name: S4).
- Company Name: Aesculap AG
- Publication Date: 2020-07-13
- Product Name: occipital-cervical-thoracic fusion system
- Recall Level: Level 2 Recall
- Recall Reason: Its clamping force decreases. This failure mode does not lead to separation, but there is a risk of displacement of the connection with the occipital rod.
- Discovering Company: B. Braun Medical (Shanghai) International Trading Co., Ltd.
- Manufacturing Company: Aesculap AG
- Summary: B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class II recall of its Occipitocervical-Thoracic Fusion System (Trade Name: S4) on July 13, 2020. The decision followed post-market surveillance where biomechanical testing by the manufacturer, Aesculap AG, revealed a decreased clamping force in the S4C transverse joint. This issue, while not leading to full separation, presents a risk of displacement at the connection with the occipital rod. The company has not received any adverse event reports related to this specific issue but is taking proactive measures to prevent potential patient risks. The recall is being conducted under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Affected product models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form. The required action is a voluntary recall of the identified medical device to ensure patient safety.

Company: https://www.keypedia.com/companies/aesculap-ag/59485d99-dc5a-4710-8d68-32cd0df59fe2