China NMPA Product Recall - Knee joint surgical instruments, hip joint surgical instruments

On August 18, 2020, Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary recall of specific knee and hip surgical instruments. This action was officially reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The primary reason for the recall was identified as a label printing error, which affected particular models and batches of the crucial surgical instruments. These affected products include those under Registration Certificate No. 20151696 for knee instruments and 20151787 for hip instruments.

The National Medical Products Administration (NMPA) documented this event with Index No. JGXX-2020-10397. The recall was designated as Class III, signifying that the use of or exposure to the violative product is not likely to cause adverse health consequences. Under the NMPA's regulatory framework, Smith & Nephew, Inc. is responsible for executing this voluntary recall. Comprehensive details regarding the precise models, specifications, and packaging of the affected medical devices are provided in the accompanying "Medical Device Recall Event Report Form." This required action ensures that distributors and healthcare professionals can accurately identify and manage the recalled instruments, upholding product quality and patient safety.