China NMPA Product Recall - ORTHOLOC 2.0/2.4 Forefoot Fracture System

On May 6, 2022, Wright Medical Technology, Inc. initiated a voluntary Class III recall for its ORTHOLOC 2.0/2.4 Forefoot Fracture System. This action was reported to the National Medical Products Administration (NMPA) by Wright Medical Devices (Shanghai) Co., Ltd., following the discovery of incorrect product packaging affecting specific models and batches. The primary issue identified was a discrepancy in product packaging. The ORTHOLOC 2.0/2.4 Forefoot Fracture System, registered under Certificate No. 20143136161, is the specific device subject to this recall. Detailed information regarding the affected product models and batches is available in the 'Medical Device Recall Event Report Form.' This voluntary recall represents a proactive measure by the company to address a packaging anomaly. A Class III recall, as designated by the NMPA, indicates that while the product has a defect, its use or exposure is not likely to cause serious adverse health consequences. The NMPA, as the overseeing regulatory body, ensures that such actions are taken to maintain product quality and public safety in the medical device sector.