China NMPA Product Recall - Non-absorbable polyester sutures (brand name: Esteban)

Ethicon LLC initiated a voluntary Class III recall for specific non-absorbable polyester sutures due to a potential product mix-up. The recall was reported to the National Medical Products Administration (NMPA) via its agent, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., on February 27, 2019, with the public announcement on March 8, 2019. The affected product, identified as Ethicon EXCEL polyester non-absorbable sutures, model W10B77, batch number MBM232, holds registration certificate No.: CFDA (i 2653392). The main issue involved Ethicon EXCEL sales packages that potentially contained Prilin sutures, distinguishable by incorrect blue packaging instead of the standard orange. While the inner Prilin suture labels were correct, the outer sales package was mismatched. These sutures are typically used for general soft tissue suturing and/or ligation, including cardiovascular, ophthalmic, and neurosurgical procedures. Crucially, the affected batch of sutures was not imported into China. Consequently, despite the global recall by Ethicon LLC, no direct corrective actions or product withdrawals were required within the Chinese market, as detailed in the official "Medical Device Recall Event Report Form." This case demonstrates adherence to medical device regulatory frameworks by promptly identifying and reporting product discrepancies.