China NMPA Product Recall - Interceed Absorbable Adhesion Barrier and Gynecare Interceed Absorbable Adhesion Barrier

The National Medical Products Administration (NMPA) has publicized a voluntary Class III recall concerning anti-adhesion medical membranes manufactured by Ethicon LLC and Ethicon SARL, as reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The affected products include Ethicon LLC's INTERCEED Absorbable Adhesion Barrier (Registration Certificate No.: 20173642107) and Ethicon SARL's GYNECARE INTERCEED Absorbable Adhesion Barrier (Registration Certificate No.: 20193140091).

This recall was prompted by interim analysis results from a clinical study involving specific models and batches of these products. The study revealed no significant difference in the incidence of adhesion between the experimental group, which used the membranes, and the control group. This outcome suggests a potential lack of efficacy for the devices in preventing adhesions, which is their primary intended purpose.

Under the NMPA's regulatory oversight, both manufacturers have initiated this voluntary recall to address the performance concern. The required action involves the removal of the identified anti-adhesion membranes from the market. Comprehensive details regarding the precise models, specifications, and affected batches are available in the accompanying "Medical Device Recall Event Report Form," ensuring transparency and enabling healthcare providers to identify and manage the recalled items appropriately.