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Preat Corp recalls Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Recalled April 5, 2023 · FDA recall Z-1285-2023 · Preat
Hazard
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. · FDA Class II
Units
26
Sold at
US Nationwide distribution in the states of TX, OR, UT, NY.
Description
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.
Product
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Manufacturer(s)
Preat Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →