China NMPA Product Recall - Root canal diagnostic equipment

KaVo (Shanghai) Dental Medical Devices Co., Ltd., representing manufacturer Ormco Corporation (USA), initiated a voluntary Level 3 recall for root canal diagnostic equipment. The recall, reported on May 22, 2015, addressed labeling inaccuracies on products shipped to China between January 28, 2015, and May 6, 2015. Ormco Corporation discovered that Chinese labels on the devices contained incorrect medical device registration certificate numbers and erroneous after-sales service organization information. This issue did not affect the product's normal use for locating the apex during endodontic treatment or measuring pulp vitality. Operating under the National Medical Products Administration (NMPA) framework, the required actions involved Ormco Corporation providing correct Chinese labels. For products in stock, shipments were frozen to allow for company-implemented label correction. For units already dispatched to customers, KaVo (Shanghai) coordinated with distributors to send recall letters alongside the accurate labels for customers to apply directly. The recall impacted 301 units imported into China.