The FDA has classified a recall (Z-1520-2026) as Class II for Waldemar Link GmbH & Co. KG's Endo-Model Replacement Plateau (Item Number: 15-8521/15). The issue stems from a potential longitudinal fracture in the screw shaft, which could lead to the detachment of the plateau screw bushing. This defect poses a risk of implant failure.

This recall impacts worldwide distribution, with specific mention of nationwide distribution in New Jersey, USA, and international distribution in Belarus, Canada, Switzerland, Colombia, Germany, Spain, and the United Kingdom. Companies involved in the distribution or use of this device should review their inventory and follow established recall procedures. While the document does not specify a compliance deadline, the nature of a device recall necessitates prompt action to mitigate patient risk.