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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Preat Corp: Astra EV 4.8mm Milled Titanium Abutments Recalled for Mislabeled Packaging

Agency Publication Date: July 8, 2024
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Summary

Preat Corp has recalled seven units of its 9006767 Astra EV 4.8mm Milled Titanium Abutments because the packages contain the incorrect dental device and are labeled incorrectly. These milled titanium abutments are intended to be used with dental implants to help support prosthetic tooth replacements. Because the package contains a different part than indicated, healthcare providers may attempt to use an incompatible component during a dental procedure. If you have had a dental implant procedure involving this specific model, contact your dental professional or the manufacturer.

Risk

The use of an incorrect or mismatched dental abutment can lead to improper fit with the dental implant, potentially causing procedural delays, implant failure, or the need for additional corrective surgeries. No specific injuries have been reported to date.

What You Should Do

  1. Check your dental records or medical device packaging for Model Number 9006767 and UDI-DI code 00842092159477.
  2. Identify if your product is from Lot Numbers ED11-20247825, ED11-20248895, ED11-20249165, or 241588.
  3. If you are a healthcare provider, immediately stop using the affected lots and sequester any remaining inventory.
  4. If you are a patient who has recently received a dental implant and are concerned about the components used, contact your dental surgeon or healthcare provider to confirm if your device was part of this recall.
  5. Contact Preat Corp at 1-800-232-7732 for further instructions regarding the return or exchange of mislabeled products.
  6. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Device Return

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

Affected Products

Product: 9006767 Astra EV 4.8mm Milled Titanium Abutment
Model / REF:
9006767
Lot Numbers:
ED11-20247825
ED11-20248895
ED11-20249165
241588
00842092159477

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94693
Status: Active
Manufacturer: Preat Corp
Sold By: Dental clinics; Surgical centers
Manufactured In: United States
Units Affected: 7 abutmens
Distributed To: California, Missouri, Nevada

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 ยท 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.