China NMPA Product Recall - Elbow Joint System – Radial Head System Implants

Wright Medical Technology, Inc. (USA) has initiated a voluntary Level II recall of its EVOLVE Modular Radial Head System-Implants, which are elbow joint systems. The recall was reported by Stryker (Beijing) Medical Devices Co., Ltd. and publicly announced by the National Medical Products Administration (NMPA) on September 7, 2022. The primary issue prompting this action is a critical mismatch between the information displayed on the external packaging labels and the actual product contained within for specific models and batches. This discrepancy could potentially lead to incorrect product identification or use. The regulatory framework under which this recall is managed is the NMPA in China, indicating the manufacturer's responsibility to ensure product safety and accurate labeling within that market. As a required action, the company is systematically recalling the affected devices, and further details regarding the specific models, specifications, and batch numbers are available in the "Medical Device Recall Event Report Form" attachment. This voluntary recall underscores the company's commitment to addressing product inconsistencies promptly to maintain patient safety and product integrity.