Medical device recalls Moderate risk

Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

Recall date
June 25, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2514-2025
FDA classification
Class II
Brand / firm
Preat Corp
Sold / distributed
US Nationwide distribution in the states of NY, FL, PA, CA, OH.

Why it was recalled

Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662

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