China NMPA Product Recall - Swanson Small Joint Orthopedic Implants

Wright Medical Technology, Inc., a U.S.-based company, initiated a voluntary Class II recall of its Swanson Small Joint Orthopedic Implants. This action was officially announced by the National Medical Products Administration (NMPA) on September 7, 2022, following a report from Wright Medical Devices (Shanghai) Co., Ltd. The core issue identified was an incorrect implant size label affixed to the outer packaging of specific models and batches of the affected products. This labeling error represents a potential risk, as it could lead to the selection and use of an improperly sized implant for patients. The regulatory framework for this action falls under the NMPA's medical device recall system, with a Class II designation, indicating a situation where product use may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The required action by the company is the voluntary recall of the implicated products, specifically those under Registration Certificate No.: 20143136168. Further details on precise models, specifications, and batch numbers are provided in an attached Medical Device Recall Event Report Form, accompanying the NMPA's public notification, to ensure comprehensive remediation of the labeling discrepancy.