The FDA has initiated a Class II device recall (Z-1517-2026) concerning Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau (Item Number: 15-8030/12). The recall is due to a manufacturing defect where the bushing of an implant screw may detach from the screw shaft, caused by a longitudinal fracture. This poses a risk to patient safety.

Manufacturers and distributors involved in the distribution of this product, particularly in the US (NJ) and internationally (Belarus, Canada, Switzerland, Colombia, Germany, Spain, UK), must cease distribution and implement recall procedures. Compliance officers should review their inventory and distribution records to identify affected units and coordinate with Waldemar Link and the FDA on remediation efforts. While no specific compliance deadline is listed, the ongoing nature of the recall implies immediate action is required.