FDAFDA · Food and drugs·Recall number Z-1285-2023
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Published April 5, 2023 · Recall initiated: February 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preat Corp
- Distributor
- US Nationwide distribution in the states of TX, OR, UT, NY.
- Lot
- UDI: 00842092161326, Lots: 211891 and 211912
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.