FDA recall Z-2514-2025

Preat Corp · Class II · device

Product

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

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-06-25
Report date
2025-09-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2514-2025