China NMPA Product Recall - Orthopedic surgical navigation system

Stryker Leibinger GmbH & Co.KG, a medical device manufacturer, initiated a voluntary Level 2 recall of its Orthopedic Surgical Navigation System (Registration Certificate No. 20163700600) through its agent, Stryker (Beijing) Medical Devices Co., Ltd. The recall, reported on October 17, 2017, and published by the National Medical Products Administration (NMPA) on October 30, 2017, addresses a manufacturing defect in the thoracic pedicle probe component. The main issue was an unexpectedly high energy setting on a laser marking machine, which caused material reduction or chipping at the marking point on the probe head. This defect could potentially affect the device's performance or safety. The Orthopedic Surgical Navigation System is used in spinal, knee, bone tumor, orthopedic implant, and hip surgeries. The recall specifically mentions affected serial numbers 10915 and 10916, impacting a quantity of 2 units in China, but also indicates broader affected regions including Australia, Canada, USA, Germany, Japan, Singapore, Taiwan, Thailand, and the United Kingdom. The required action is this voluntary recall to remove the defective products from the market, with further details on product models and batch specifics available in the Medical Device Recall Event Report Form.