Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00842092161395/Lot #OF018355
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Preat Corp
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Product Codes/Lot Numbers:
UDI-DI: 00842092161395/Lot #OF018355
Distribution:
Distributed in: US, FL, CA, OR, TX, OH, SC, NJ
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0154-2024
Related Recalls
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the correct orientation, resulting in restoration delay.
Due to manufacturing error, digital analog rotational feature is 180 degrees off.
Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.