Z-2514-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 10, 2025
- Initiation Date
- June 25, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
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 Pattern
US Nationwide distribution in the states of NY, FL, PA, CA, OH.
Code Information
UDI-DI: 00842092169599. Lot: 277097