China NMPA Product Recall - Injector

The National Medical Products Administration (NMPA) published a notification on January 13, 2017, detailing a voluntary Class II recall initiated by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. The recall addresses a critical product defect in their PFNA blade injector. Investigations revealed that the injector's laser welding point could partially or completely break, causing the handle to separate from the internal shaft of the surgical instrument. This malfunction presents a significant safety concern during surgical use. In response, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. proactively opted to recall the affected products. A Class II recall designation indicates that the product's use or exposure might lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Full particulars, including specific models, specifications, and batch numbers of the recalled items, are available in the associated 'Medical Device Recall Event Report Form' and its attachments. This action highlights the company's commitment to ensuring product safety and adherence to NMPA regulations.