Z-1285-2023Class II

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

Name: Z-1285-2023 Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Creator: Preat Corp
Published: 2023-02-21
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2023-02-21 / Open, Classified / root cause: manufacturing process

FDA source

Preat Corp began a recall of Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 on 2023-02-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1285-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-21
Posted: 2023-03-24
Recalling firm: PREAT Corporation
Product: Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732
Quantity in commerce: 26
Distribution: US Nationwide distribution in the states of TX, OR, UT, NY.
Product codes and lots: UDI: 00842092161326, Lots: 211891 and 211912

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1285-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1285-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-05	2023-03-24

Product code NHA

K220823Class IIPreat AbutmentsPreat Corporation / cleared 2022-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)