Preat Corp: Titanium Dental Abutments Recalled Due to Manufacturing Defect

Agency Publication Date: March 20, 2024

Summary

Preat Corp is recalling 561 units of Preat Nobel Active/Conical-compatible RP Titanium Blanks because of a manufacturing defect. The screw seat location on the abutment was made too high, which prevents the mounting screw from securely fastening into the dental implant. This recall involves model number 9000967 and was distributed in Arizona, Ohio, and Pennsylvania. Consumers should contact their dental healthcare provider or the manufacturer regarding the issue.

Risk

The incorrect screw seat height causes the mating screw to have a shorter engagement length into the implant, which may lead to the dental prosthetic loosening or failing to remain properly attached.

What You Should Do

Check your medical or dental records for Preat Nobel Active/Conical-compatible RP Titanium Blanks (REF 9000967).
Verify if your product matches one of the following affected lot numbers: 235650, 234294, 233667, 233885, 233439, or 231489.
If you are a patient, contact your dentist or oral surgeon to determine if an affected abutment was used in your procedure and to discuss next steps.
If you are a healthcare provider or laboratory, stop using any remaining inventory from the affected lots and contact Preat Corp at 1-800-232-7732 for instructions on returning the product.
For further questions or to discuss potential remedies, contact Preat Corp directly or visit their website for recall information.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional assistance.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Preat Nobel Active/Conical-compatible RP Titanium Blank

Model / REF:

9000967

REF 9000967

UPC Codes:

00842092165867

Lot Numbers:

235650

234294

233667

233885

233439

231489

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94032

Status: Active

Manufacturer: Preat Corp

Sold By: Dental laboratories; Healthcare providers

Manufactured In: United States

Units Affected: 561 units

Distributed To: Arizona, Ohio, Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medical or dental records for Preat Nobel Active/Conical-compatible RP Titanium Blanks (REF 9000967).

Verify if your product matches one of the following affected lot numbers: 235650, 234294, 233667, 233885, 233439, or 231489.

If you are a patient, contact your dentist or oral surgeon to determine if an affected abutment was used in your procedure and to discuss next steps.

If you are a healthcare provider or laboratory, stop using any remaining inventory from the affected lots and contact Preat Corp at 1-800-232-7732 for instructions on returning the product.

For further questions or to discuss potential remedies, contact Preat Corp directly or visit their website for recall information.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional assistance.