China NMPA Product Recall - Knee joint surgical instruments

The National Medical Products Administration (NMPA) published details on November 7, 2025, regarding a voluntary recall initiated by Smith & Nephew, Inc. This recall pertains to specific batches of their knee surgical instruments, identified under Recordation No. 20151696. The primary reason for this action is the discovery of labeling errors on some of these medical devices. Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., the manufacturer's subsidiary, formally reported this compliance issue.

Categorized as a Class III recall, this measure represents a proactive step by Smith & Nephew to address the identified product inaccuracies. Regulatory frameworks, such as those enforced by the NMPA, require manufacturers to ensure the accuracy and clarity of product labeling to safeguard patient safety and facilitate correct product usage. It is important to note that this specific recall does not impact the market within China. The required actions involve the thorough identification and removal of all instruments from the designated affected batches from further distribution. Comprehensive details concerning the specific models, specifications, and batch numbers of the impacted devices are available in an attached "Medical Devices List" and a formal Medical Device Recall Event Report Form. This action underscores the commitment to maintaining high standards of product quality and regulatory adherence.