RecallRadar

FDA Device recall Z-2514-2025

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

On 2025-09-10 the FDA classified a Class II recall of NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662 by Preat, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2514-2025
ClassificationClass II
Statusongoing
Initiated2025-06-25
Published2025-09-10
Last updated2026-09-13 11:57 UTC
CompanyPreat
DistributionUS

Product

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

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.

Identifiers

code_infoUDI-DI: 00842092169599. Lot: 277097

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2514-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.