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

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.