Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Summary
The FDA issued a Class II for Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Sing by Preat Corp. Reason: The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage.
Details
Source
Device Recall
External ID
Z-0153-2024
Action Date
2023-11-01
Status
Ongoing
Category
device
Product Description
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Lot/Code Info: UDI-DI: 00842092161388/Lot #OF018357
Quantity Affected: 23 units
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
Distribution
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-18
Company
Santa Maria, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Preat Corp has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preat Corp) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preat Corp have FDA actions?
Preat Corp has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0153-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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