Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1285-2023 — Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

U.S. FDA — Device Enforcement · United States · 2023-02-21 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1285-2023
Date of alert
2023-02-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Preat Corp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00842092161326
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.