China NMPA Product Recall - Linear cutting stapler and staple cartridge (trade name: ADVANT55)

Ethicon Endo-Surgery, LLC initiated a voluntary recall in China for its linear anastomosing device and staple cartridge, marketed under the trade name ADVANT55. The recall, reported on December 15, 2010, and published by the National Medical Products Administration (NMPA) on January 18, 2011, stemmed from an significant labeling error. Due to an operator's failure to follow standard operating procedures for affixing and checking labels, some units of the ADVANT55 product had a Chinese label belonging to a different product. Shanghai Maisiqiang Medical Devices Co., Ltd., the responsible unit in China, reported this issue. The affected product, model JJ55G, had an import quantity of 1848 units, with 434 sold in China. The NMPA instructed Food and Drug Administrations across all provinces and regions to oversee this recall. As a corrective action, all affected distributors and hospitals were promptly notified to return unsold and unused products identified with the confirmed labeling errors for replacement, ensuring patient safety and regulatory compliance.