# China NMPA Product Recall - Nickel-titanium support system

Source: https://www.globalkeysolutions.net/records/china_product_recall/contis-shanghai-medical-devices-co-ltd/8f7087b7-ff21-401b-81cf-61410775fb35/
Source feed: China

> China NMPA product recall for Nickel-titanium support system by Contis (Shanghai) Medical Devices Co., Ltd. published March 17, 2017. Recall level: Class II Recall. Contis (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Nickel-Tita

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Contis (Shanghai) Medical Devices Co., Ltd. voluntarily recalls nickel-titanium stent systems.
- Company Name: Contis (Shanghai) Medical Devices Co., Ltd.
- Publication Date: 2017-03-17
- Product Name: Nickel-titanium support system
- Recall Level: Class II Recall
- Recall Reason: Some products experience release difficulties or release failures.
- Discovering Company: Contis (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Contis (Shanghai) Medical Devices Co., Ltd.
- Summary: Contis (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its Nickel-Titanium Stent Systems, as announced by the National Medical Products Administration (NMPA) on March 17, 2017. The company discovered a significant performance issue where certain products exhibited "release difficulties or failures," which could potentially impact patient safety and the effectiveness of the device during medical procedures. This proactive measure by Contis Shanghai aligns with the stringent regulatory framework of the NMPA, China's primary authority for medical products. The recall, stemming from the company's internal quality surveillance, did not specify external inspection dates but rather the firm's self-identification of the issue. As part of the required actions, Contis Shanghai is actively retrieving the affected Nickel-Titanium Stent Systems from the market. The specific models and specifications included in this recall are comprehensively detailed in the official "Medical Device Recall Event Report Form." This action aims to prevent further use of the non-conforming devices and mitigate potential risks to patients, ensuring adherence to product safety standards.

Company: https://www.globalkeysolutions.net/companies/contis-shanghai-medical-devices-co-ltd/17e6f919-5d81-4fa7-b459-0a5ef5a882ca/