Reported Apr 5, 2023 · Ongoing
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Preat Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Preat Corp · 2625 Skyway Dr Ste B · Santa Maria, CA · 93455-1405
Is this the product you have?
- Neodent GM X 6mm Engaging Titanium Base
- REF9007162
- Lot codes and dates
- UDI00842092161326
- Lots211891 and 211912
- Amount recalled
- 26
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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