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FDAJanuary 12, 2026device

Endo-Model Replacement Plateau; Item Number: 15-2835/12;

Official recall recorded by the U.S. Food & Drug Administration.

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.

What to do

FDA enforcement status: Ongoing

Brands named

waldemar link gmbh co kg mfg sitewaldemarwaldemar link

UPCs

04026575316564

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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