FDA Medical devices recall ·
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base recall
- Recall number
- Z-2514-2025
- Date
- (initiated June 25, 2025)
- Company / brand
- Preat Corp
2625 Skyway Dr Ste B, Santa Maria, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 11
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00842092169599. Lot: 277097
Distribution
US Nationwide distribution in the states of NY, FL, PA, CA, OH.
States: California Florida New York Ohio Pennsylvania
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2514-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.