Neodent GM X 6mm Engaging Titanium Base recall
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Why was Neodent GM X 6mm Engaging Titanium Base recalled?
Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00842092161326, Lots: 211891 and 211912
- Product
- Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- Recalling firm
- Preat Corp
- Quantity
- 26
- Distribution
- US Nationwide distribution in the states of TX, OR, UT, NY.
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)