China NMPA Product Recall - Orthopedic surgical navigation system

Stryker Leibinger GmbH & Co.KG, through its agent Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Level 2 recall for its Orthopedic Surgical Navigation System (NMPA Registration Certificate 20163700600). This action was reported on October 17, 2017, and publicly announced by the National Medical Products Administration (NMPA) on October 30, 2017. The recall stems from a manufacturing issue where the laser marking machine, used for thoracic pedicle probes, had an energy setting exceeding specifications. This resulted in unintended material reduction and chipping at the probe head's marking location, potentially compromising the device's integrity. The regulatory oversight for this recall falls under the NMPA's framework for medical device safety in China. As a required corrective action, Stryker is recalling affected products, specifically models such as 6002-350-000, from the Chinese market and other international regions including Australia, Canada, Germany, Japan, Singapore, Taiwan, Thailand, the UK, and the USA, to mitigate potential risks and ensure product safety.