Preat Neodent Dental Healing Abutment Recalled for Dimensional Defect
Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments due to a dimensional condition that may create a gap between the abutment and implant, potentially allowing microleakage. Affected devices were distributed in multiple US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a dental implant abutment with a dimensional defect that may create a gap allowing microleakage. Although no illnesses or injuries have been reported, the product poses a clear risk of harm to patients. Risk-of-harm products without reported injury typically receive a High rating.
Plain-English summary
Preat Corp is recalling Preat REF 9007121 Neodent GM x 2mm Healing Abutments. The devices are dental healing abutments used in oral surgical implant procedures.
The recall was initiated due to a dimensional condition in the abutments that may lead to a gap between the healing abutment and the dental implant, potentially allowing microleakage.
Affected devices include 13 units distributed in the United States across Florida, California, Oregon, Texas, Ohio, South Carolina, and New Jersey. The recalled devices have Lot # OF018356 and UDI-DI 00842092161364.
Healthcare providers and patients who may have been affected by this recall should consult with the device manufacturer, their healthcare provider, or the FDA for specific guidance.
The recalled product
- Product
- Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Manufacturer
- Preat Corp
- Hazard
- microleakage
- fit-gap
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00842092161364/Lot # OF018356
Distribution
Distributed in 7 states:
- CA
- FL
- NJ
- OH
- OR
- SC
- TX
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