China NMPA Product Recall - Non-sterile surgical instruments for the shoulder joint (DePuy, Ireland)

On December 30, 2021, the National Medical Products Administration (NMPA) announced a Level II voluntary recall initiated by DePuy (Ireland) Limited, a manufacturer of medical devices. This recall, reported by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., concerns specific models and batches of non-sterile surgical instruments designed for shoulder joints. The primary issue identified for these products is a potential manufacturing defect where the plug hole diameter may be too small. This deviation could potentially affect the instruments' intended performance or safety during surgical use. As a proactive measure to ensure product quality and patient safety, DePuy (Ireland) Limited is voluntarily recalling the affected products. A Level II recall indicates that the product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences being remote. Further details regarding the specific models, specifications, and batch numbers of the affected products are available in an attached 'Medical Device Table' and a recall event report form, which are to be consulted for comprehensive information.