The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0154-2024·Announced 2023-11-01

Preat Neodent Healing Abutments Recalled for Dimensional Gap Risk

Preat Corp is recalling Neodent dental healing abutments (REF 9007124) due to a dimensional condition that may cause gaps between the abutment and implant, potentially allowing microleakage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported injuries or illnesses documented in the source. The hazard is described as a potential risk—a dimensional condition that 'may lead to' microleakage—rather than confirmed harm. Per the severity rubric, risk-of-harm products without documented injury fall into the High category.

Plain-English summary

Preat Corp is recalling Preat REF 9007124 Neodent GM x 4mm Healing Abutment (Wide). This is a non-sterile, single-use dental implant component marked for prescription use.

The recalled abutments contain a dimensional condition that may result in a gap between the healing abutment and the implant, potentially allowing for microleakage.

The recalled product was distributed in the United States to locations in Florida, California, Oregon, Texas, Ohio, South Carolina, and New Jersey. The affected lot number is OF018355, identified by UDI-DI 00842092161395.

Patients and dental professionals should contact Preat Corp if they have questions about affected units or need guidance on handling received products.

The recalled product

Product
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Manufacturer
Preat Corp
Category
Medical Device — Dental Implant Component
Hazard
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00842092161395/Lot #OF018355

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 3 recalled by Preat Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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