FDA recall Z-1285-2023

Preat Corp · Class II · device

Product

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

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.

Key facts

Status
Ongoing
Initiation date
2023-02-21
Report date
2023-04-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Santa Maria, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1285-2023