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.
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: US Nationwide distribution in the states of NY, FL, PA, CA, OH. Quantity: 11 Lot/code info: UDI-DI: 00842092169599. Lot: 277097
00842092169599
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.