# FDA recall Z-1285-2023

> **Preat Corp** · Class II · device recall initiated 2023-02-21.

## 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

- **Recall number:** Z-1285-2023
- **Recalling firm:** Preat Corp
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1285-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1285-2023. Source: US FDA. Licensed CC0.

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