China NMPA Product Recall - Patch (product name: PHYSIOMESH)

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its ETHICON PHYSIOMESH Flexible Composite Mesh patches, as reported to the National Medical Products Administration (NMPA) on June 3, 2016, with the recall details published on August 29, 2016. This action was prompted by internal company research, which analyzed unpublished data from two independent hernia registries, the German Hernia Registry Study and the Danish Hernia Database DHDB. These studies indicated that the PHYSIOMESH patch exhibited a higher recurrence rate or reoperation rate compared to other patches when used in laparoscopic abdominal wall hernia repair surgeries, raising significant safety concerns.