FDA Device recall Z-1285-2023
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- FDA Device
- Class II
- ongoing
- Published 2023-04-05
On 2023-04-05 the FDA classified a Class II recall of Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 by Preat, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1285-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-21 |
| Published | 2023-04-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Preat |
| Distribution | US |
Product
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Reason
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.
Identifiers
| code_info | UDI: 00842092161326, Lots: 211891 and 211912 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1285-2023%22
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