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. This action was reported by the National Medical Products Administration (NMPA) on October 30, 2017, following a recall event report dated October 17, 2017.

The recall was necessitated by a manufacturing issue involving the system's thoracic pedicle probe. It was discovered that a laser marking machine used for marking the probe's distance operated with an energy value higher than intended. This excessive energy caused material reduction and chipping at the probe head's marking location.

The affected product, registered under National Medical Device Registration Certificate 20163700600, is used for navigation and positioning in various orthopedic surgeries, including spinal, knee, bone tumor, implant, and hip procedures. The recall extends globally, impacting regions such as Australia, Canada, China, Germany, Japan, Singapore, Taiwan, Thailand, the United Kingdom, and the USA. The company's immediate action is to recall affected units to mitigate potential risks and uphold product quality standards under NMPA oversight.