The FDA has initiated a Class II device recall, identified as Z-1519-2026, for Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau (Item Number: 15-8521/11). The recall is due to a defect where the bushing of a plateau screw may detach from the screw shaft, posing a potential risk. This recall affects distribution globally, including specific areas within the United States (NJ) and several other countries.

Manufacturers and distributors involved in the supply chain of this device must immediately review their inventory and distribution records to identify affected units. Compliance with FDA recall procedures, including notification to downstream customers and potential return or destruction of affected products, is mandatory. While no specific compliance deadline is listed, prompt action is expected given the nature of a device recall.