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Medium risk Medical DevicesClass II

Endo-Model Replacement Plateau Recall

Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Updated January 12, 2026

The Endo-Model Replacement Plateau implant (Item Number 15-0027/11) is being recalled because the bushing on the plateau screw can detach from the shaft due to a longitudinal fracture, which could compromise the implant's function.

Is the Waldemar Link GmbH & Co. KG (Mfg Site) recalled? Yes. This product was recalled by FDA on January 12, 2026. Details below.

What is recalled

Endo-Model Replacement Plateau; Item Number: 15-0027/11, manufactured by Waldemar Link GmbH & Co. KG

Am I affected

You're affected if you have had this implant surgically placed and the item number on your implant paperwork or surgical records is 15-0027/11.

What to do right now

Contact your orthopedic surgeon or the hospital where your implant was placed to discuss whether your specific implant is affected and what monitoring or follow-up care you may need.

The hazard

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Brands affected

Waldemar Link GmbH & Co. KG (Mfg Site)
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-1521-2026
Classification
Class II
Recalled
January 12, 2026
Read the official notice

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