China NMPA Product Recall - Knee Orthopedic Kit

MAKO Surgical Corp., in collaboration with Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class II recall of its knee orthotic kit (Registration No.: 20180529). This action, overseen by the National Medical Products Administration (NMPA), stems from a report detailing a critical product defect: a handle connecting pin detaching from the knee orthotic tool puller. The issue was discovered during a surgical procedure, highlighting a potential risk to patient safety and operational integrity. The recall notice, published on December 29, 2018, specifies that the Class II classification indicates that the use of or exposure to the defective product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. MAKO Surgical Corp. is undertaking this recall to address the identified manufacturing flaw. Further comprehensive details, including specific models, specifications, and batch numbers of the affected products, are formally documented in the "Medical Device Recall Event Report Form." This corrective measure emphasizes the necessity for rigorous quality control in medical device manufacturing to prevent such failures during critical medical interventions.