GC FujiCEM™ 2 441000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D6584410001), received between Dec 18, 2017 and Jan 11, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT RECENTLY HAD ALLERGY TESTING DONE AND DETERMINED TO HAVE ALLERGIES TO SOME OF THE INGREDIENTS IN DENTAL MATERIAL IE 2 HYDROXYETHYL METHACRYLATE , POLYMETHYLMETHACRYLATE AND AMIODARONE. DR. REPORTED ON (B)(6) 2019 THAT THE PATIENT HAD A STRONG REACTION TO HEMA ( HYDROXYETHYL METHACRYLATE). HER SYMPTOMS HAVE BEEN A REOCCURRING FACIAL RASH. THE PATIENT IS BEING TREATED WITH FACIAL CREAM. DR. IS EVALUATING IF CREAM WILL RESOLVE THE PROBLEM. IF NOT, WILL THEN CONSIDER TO REMOVE THE RESTORATION WITH 3 UNIT BRIDGE. THE MOST RECENT ONE WAS PLACED WITH FUJICEM 2 IN 2016. THEY DO NOT KNOW WHAT OTHER CEMENTS WERE USED ON HER OTHER RESTORATIONS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 8241882 ↗
• InjuryDec 18, 2017Patient-Device Incompatibility

  AFTER PLACING A CROWN THE PATIENT EXPERIENCED ITCHING,SWELLING, AND SORES IN THE MOUTH. DR REMOVED THE CROWN & CEMENT AND PATIENT WAS PLACED ON STEROID AND THE SYMPTOMS DISSIPATED. PATIENT SAW AN ALLERGIST WHO DETERMINED THAT THE PATIENT IS ALLERGIC TO THE FUJICEM2.

  Patient problems: Hypersensitivity/Allergic reaction; Irritation; Itching Sensation; Swelling

  MAUDE report 7126964 ↗