China NMPA Product Recall - extraosseous system

Smith & Nephew, Inc., a medical device manufacturer, initiated a voluntary Class III recall of its Bone Needle System, specifically the 1.6mm Stainless steel skull needle (150mm), due to critical labeling errors. The recall was publicly reported by the National Medical Products Administration (NMPA) on April 8, 2018, with the recall event report submitted on March 12, 2018, by Smith & Nephew Medical Products International Trading (Shanghai) Co., Ltd. The primary issue identified was the incorrect expiration date printed on the labels and packaging boxes for affected product batches. For instance, batch number 17GK00029 was erroneously labeled with an expiration date of July 21, 2017, instead of the correct date of July 19, 2027. This discrepancy poses a risk by potentially leading to the use of expired products or the premature disposal of viable products. Under the NMPA's regulatory framework, Smith & Nephew conducted a voluntary Class III recall, indicating a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. The required action involves retrieving the mislabeled products from the market to prevent any potential risks associated with the incorrect expiration information. This recall specifically impacts operations in China, among other international regions.