Preat Neodent Healing Abutment Recalled Due to Dimensional Defect
Preat Corp is recalling 23 Neodent GM x 4mm Healing Abutments due to a dimensional defect that may allow microleakage between the abutment and implant. Affected units were distributed to dental practices 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 medical device recall with no reported illnesses or injuries. The dimensional defect in the healing abutment presents a potential risk of harm through microleakage and implant compromise, which may require clinical intervention, warranting a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Preat Corp is recalling the Preat REF 9007123 Neodent GM x 4mm Healing Abutment, a dental implant component manufactured as a non-sterile, single-use device. The recall affects 23 units distributed to dental practices in Florida, California, Oregon, Texas, Ohio, South Carolina, and New Jersey.
The healing abutments contain a dimensional condition that may create a gap between the abutment and the implant, potentially allowing microleakage. This defect could compromise the integrity of the implant and may require corrective clinical intervention.
This recall is issued by the FDA as a Class II device recall (FDA Recall Number Z-0153-2024, Lot #OF018357, UDI-DI 00842092161388). Dentists who have received affected units should discontinue use immediately and contact Preat Corp for replacement or return instructions. Patients who may have received this device should contact their dental provider to determine if they are affected and to discuss appropriate follow-up care.
The recalled product
- Product
- Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
- Manufacturer
- Preat Corp
- Hazard
- dimensional-defect
- microleakage
- implant-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: 00842092161388/Lot #OF018357
Distribution
Distributed in 7 states:
- CA
- FL
- NJ
- OH
- OR
- SC
- TX
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