China NMPA Product Recall - Surgical head frame

Integra LifeSciences Corporation initiated a voluntary Class II recall for its MAYFIELD™ Cranial Stabilization Products, specifically surgical headrests, as published by the National Medical Products Administration (NMPA) on March 10, 2015. The recall addresses a critical manufacturing defect where the locking handle of the 360-degree base connector may malfunction during use, failing to secure properly. Investigations revealed the root cause to be an excessive gap between the cam rod's inner diameter and its mating rod, reducing contact and causing excessive tension that prevents proper locking. Affected products include all batches manufactured and distributed globally since October 2006. While 71 malfunction complaints were received internationally, no patient injuries or adverse consequences were reported, and no complaints were received for products sold in China. Under the NMPA's regulatory oversight, Integra LifeSciences is implementing a corrective action plan. This involves sending recall notices to distributors. Subsequently, Integra will coordinate directly with end-users, such as hospitals and agents, to collect the affected devices for complimentary repair and stringent quality inspection before their return. This proactive recall aims to mitigate potential risks associated with the device's failure to lock securely during surgical procedures.