Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2514-2025 · Posted 2025-09-03

Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2025-06-25
Product Quantity11

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.

Firm Action

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 [email protected] If you have any questions or concerns, please call/email the firm at: (800) 232-7732, [email protected]

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183518Preat AbutmentsPreat Corporation · 2019-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑