FDA DeviceClass IINotable
FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2836/11;
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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2026-03-18 · FDA_DEVICE
FDA Recall: Endo-Model Replacement Plateau; Item Number: 15-2835/12;
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2026-03-18 · FDA_DEVICE
FDA Recall: Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
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