Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base

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.

On 06/25/2025, recall notices were mailed to customers who were asked to do the following: 1) Stop/cease use of the product in the scope of this recall 2) This product shall be discarded or returned to the recalling firm 2) All personnel within your company should be made aware of the issue. Any customers to which this product has been further distributed should be notified be provided a copy of this notification and informed to notify their customers. 3) Complete and return the Customer Response Form via email to mgonzales@younginnovations.com If you have any questions or concerns, please call/email the firm at: (800) 232-7732, mgonzales@younginnovations.com

• FDA enforcement recordOfficial FDA database entry for Z-2514-2025
• FDA 510(k) clearance · K183518The device's official FDA premarket clearance record
• FDA device classification · NHAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.3630The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Preat CorpSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.