Endo-Model Replacement Plateau; Item Number: 15-8030/12;
FDA Recall #Z-1517-2026 — Class II — January 12, 2026
Product Description
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Reason for Recall
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Recalling Firm
Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4 units (all OUS)
Distribution
Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Code Information
Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated