Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
Reason for recall: Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient. Distribution: US Nationwide distribution in the states of TX, OR, UT, NY. Quantity: 26 Lot/code info: UDI: 00842092161326, Lots: 211891 and 211912
00842092161326
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.