Preat Corp: Device Recall

Recall #Z-2514-2025 · 06/25/2025

Class II: Risk

Recall Details

Recall Number
Z-2514-2025
Classification
Class II
Product Type
Device
Recalling Firm
Preat Corp
Status
Ongoing
Date Initiated
06/25/2025
Location
Santa Maria, CA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11

Reason for Recall

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.

Product Description

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

Distribution Pattern

US Nationwide distribution in the states of NY, FL, PA, CA, OH.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.