# China NMPA Product Recall - Tension-free transvaginal urethral suspension system, transobturator transvaginal anterior vaginal wall urethral suspension device

Source: https://www.globalkeysolutions.net/records/china_product_recall/ethicon-llc-and-ethicon-sarl/cbfb326c-7607-488e-8ab0-e214dc151045/
Source feed: China

> China NMPA product recall for Tension-free transvaginal urethral suspension system, transobturator transvaginal anterior vaginal wall urethral suspension device by Ethicon LLC and Ethicon SARL published November 30, 2020. Recall level: Level 3 Recall. Ethicon SARL, the manufacturer, has initiated a voluntary Class III recall of two medical devices: t

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ethicon SARL is voluntarily recalling its tension-free transvaginal urethral suspension system and transobturator transvaginal anterior wall urethral suspension.
- Company Name: Ethicon LLC and Ethicon SARL
- Publication Date: 2020-11-30
- Product Name: Tension-free transvaginal urethral suspension system, transobturator transvaginal anterior vaginal wall urethral suspension device
- Recall Level: Level 3 Recall
- Recall Reason: On-site safety notices have been issued in South Korea for specific models and batches of products, requiring companies to inform their customers of relevant precautions.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Ethicon LLC and Ethicon SARL
- Summary: Ethicon SARL, the manufacturer, has initiated a voluntary Class III recall of two medical devices: tension-free transvaginal urethral suspension systems (Registration Certificate No.: 20143185234) and transobturator transvaginal anterior wall urethral suspension devices (Registration Certificate No.: 20153183294). This action, indexed by the National Medical Products Administration (NMPA) as JGXX-2020-10660 and published on November 30, 2020, follows a field safety notice first issued in South Korea concerning specific models and batches of these products. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. reported this recall, indicating their responsibility to inform customers about the necessary precautions related to the affected devices. While the precise nature of the safety issue is not detailed in the NMPA notice, the Class III classification suggests a situation where use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The regulatory framework is overseen by the NMPA, ensuring product safety within China. Required actions include the voluntary withdrawal of these specific products from the market and customer notification regarding their safe handling or return, with full details available in the attached Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/ethicon-llc-and-ethicon-sarl/ac42af6b-ba66-4081-ac44-0a028d006864/