Z-0153-2024Class II

Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Name: Z-0153-2024 Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Creator: Preat Corp
Published: 2023-07-18
License: https://open.fda.gov/license/

PREAT Corporation / initiated 2023-07-18 / Open, Classified

FDA source

Preat Corp began a recall of Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental on 2023-07-18. FDA classified it as Class II and gives the reason as "The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0153-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-18
Posted: 2023-10-24
Recalling firm: PREAT Corporation
Product: Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
FDA root cause: Process change control
Action: On August 4, 2023, Preat Corporation issued a "Urgent Medical Device Recall" notification via: USPS. Preat ask consignees to take the following actions: Product within the scope of the recall shall be discarded or returned to Preat Corporation. Instructions for the return will be provided. Complete and email response form to Nichole Fetterman, E-Mail: [email protected] or mail to Preat Corporation, Attn. Nichole Fetterman, 2625 Skyway Drive, Ste. B, Santa Maria, CA 93455
Quantity in commerce: 23 units
Distribution: US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Product codes and lots: UDI-DI: 00842092161388/Lot #OF018357

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0153-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0152-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0153-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23
Z-0154-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-23

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)