FDAClass IINovember 1, 2023

Preat REF 9007121 recall

Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental

Why was Preat REF 9007121 recalled?

The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00842092161364/Lot # OF018356

Product
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Recalling firm
Preat Corp
Quantity
13 units
Distribution
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Recall date
November 1, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls