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FDA DeviceClass IINotable

FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Date: 2026-03-18
Brand: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

7 units (OUS only)

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