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Recall Observatory FDA recall evidence

Device product

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

Z-2514-2025

June 25, 2025

Class II

Product summary

Firm
Preat Corp
Event
Event 97239
Status
Ongoing
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-2514-2025

Official wording

Reason: 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.

Code information: UDI-DI: 00842092169599. Lot: 277097

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.