Preat Corp: Medical Device Recall in 2023 - (Recall #: Z-1285-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 21, 2023

Date Posted: April 5, 2023

Recall Number: Z-1285-2023

Event ID: 91876

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.

Status: Ongoing

Product Quantity: 26

Code Information:

UDI: 00842092161326, Lots: 211891 and 211912

Distribution Pattern:

US Nationwide distribution in the states of TX, OR, UT, NY.

Voluntary or Mandated:

Voluntary: Firm initiated