Dental Implant Titanium Base Recalled for Stability and Fracture Risk
Preat Corp is recalling Neodent GM X 6mm titanium base components due to a dimensional defect causing vertical movement. This instability may lead to abutment fracture and potential ingestion of dental materials by patients.
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 with no reported illnesses or injuries. The hazard is a structural defect in a medical device with potential for patient harm, but the injury remains theoretical and unreported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Preat Corp is recalling Neodent GM X 6mm Engaging Titanium Base components (REF: 9007162) distributed nationwide in Texas, Oregon, Utah, and New York. Affected lot numbers are 211891 and 211912, with 26 units involved.
The recalled titanium base contains a dimensional condition that allows vertical movement of the component after the prosthetic screw is tightened to the manufacturer's recommended torque value. When installed on a dental implant, this movement may cause fracture of the abutment or screw.
If the abutment, screw, or crown fractures, there is a risk that pieces could be ingested by the patient.
Dental professionals and patients who have received these components should contact Preat Corp or their dental provider. Do not attempt to adjust or remove the component without professional guidance. Your dentist can evaluate whether your implant is affected and determine appropriate treatment.
The recalled product
- Product
- Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- Manufacturer
- Preat Corp
- Hazard
- dimensional-defect
- component-instability
- abutment-fracture
- ingestion-risk
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 (2)
- UDI: 00842092161326
- Lots: 211891 and 211912
Distribution
Distributed nationwide across the United States.
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