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 of its Orthopedic Surgical Navigation System (National Medical Device Registration Certificate 20163700600). This action was reported on October 17, 2017, and published by the National Medical Products Administration (NMPA) on October 30, 2017. The core issue stemmed from a manufacturing flaw where the laser marking machine, used for the thoracic pedicle probe, was set to an unexpectedly high energy value. This led to material reduction and chipping at the probe head's marking location, potentially affecting the device's integrity. Consequently, Stryker recalled specific product models, including 6002-350-000, with serial numbers 10915 and 10916. The recall spanned multiple countries and regions, such as Australia, Canada, China, Germany, Japan, Singapore, Taiwan, Thailand, the United Kingdom, and the USA. Under the NMPA's regulatory framework, Stryker undertook this proactive measure to address the material defect and ensure the safety and reliability of its medical devices globally, despite no sales of the affected batches being reported in China.