The FDA has initiated a Class II device recall for Waldemar Link's Endo-Model Replacement Plateau (item number 15-8521/09). The recall, designated Z-1518-2026, addresses a defect where the bushing could detach from the screw shaft due to a longitudinal fracture. This recall impacts worldwide distribution, including specific US states and several countries.

Manufacturers and healthcare providers who have distributed or used these devices must cease use and follow the manufacturer's instructions for return or replacement. Compliance officers should review their inventory and distribution records to identify affected units and ensure proper handling according to the recall procedures. Failure to comply with recall procedures can result in regulatory action by the FDA.