China NMPA Product Recall - DARCO Plating System for small bone fracture fixation

Wright Medical Technology, Inc., through its subsidiary Wright Medical Devices (Shanghai) Co., Ltd., initiated a voluntary Class III recall of several medical devices. This action was announced by the National Medical Products Administration (NMPA) on December 10, 2021. The affected products include the DARCO Plating System for Small Bone Fracture Fixation, the Total Ankle System, and the Foot and Ankle System, each identified by specific registration certificates. The primary issue prompting this recall is incorrect packaging discovered in particular models and batches of these products. While specific inspection dates are not detailed, the NMPA's announcement signifies the official communication regarding the recall. Under the NMPA's regulatory framework, a Level III recall indicates that the use of or exposure to the violative product is unlikely to cause adverse health consequences. As a required action, Wright Medical Technology, Inc. is voluntarily withdrawing these products from the market to rectify the identified packaging discrepancy. Comprehensive details concerning the exact models, specifications, and batches involved are available in the attached "Medical Device Recall Event Report Form".