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FDAFebruary 21, 2023device

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

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

The hazard

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

What to do

FDA enforcement status: Ongoing

Brands named

preat

UPCs

00842092161326

Recall history

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

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Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 — Recall Details · AllClear