China NMPA Product Recall - Knee joint surgical instruments

Smith & Nephew, Inc. initiated a voluntary Class III recall for certain knee surgical instruments, as publicly reported on January 24, 2019, following a recall event report dated January 23, 2019. The recall, reported by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd., was prompted by a manufacturing error involving a misplaced laser-etched handle on the instruments. This issue represents a deviation from manufacturing specifications and quality control during production. The affected products are identifiable by Registration Certificate No.: 20151696. The National Medical Products Administration (NMPA) framework designates this as a Class III recall, indicating that while a defect exists, the use of or exposure to the instruments is not anticipated to cause serious adverse health consequences. The primary required action involves the systematic removal of these specific knee surgical instruments from the market to ensure product integrity and adherence to quality standards. Comprehensive details concerning affected product models, specifications, and batch numbers are documented in the "Medical Device Recall Event Report Form."