NR Line GFX3011SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08809460302356), received between Oct 12, 2017 and Feb 13, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (6 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 4 MONTHS AFTER IMPLANT PLACEMENT. PATIENT'S X-RAY WAS PROVIDED. THE BONE QUALITY WAS TYPE III. THE ORAL HYGIENE AROUND IMPLANT SITE WAS MODERATE. BONE RESORPTION WAS FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration

  MAUDE report 24339827 ↗
• InjuryJan 8, 2025Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE WITHIN 1 YEAR, APPROXIMATELY 2 MONTHS AFTER IMPLANT PLACEMENT. THE BONE QUALITY WAS TYPE I. THE ORAL HYGIENE AROUND IMPLANT SITE WAS GOOD. LOCAL INFECTION & PAIN WERE FOUND DURING THE REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS NOT USED IN IMPLANT PLACEMENT SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 21105990 ↗
• InjuryFeb 19, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO OSSEOINTEGRATION FAILURE, 6 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE I, AND ORAL HYGIENE AROUND THE IMPLANT WAS GOOD. LOCAL INFECTION WAS OBSERVED DURING THE IMPLANT REMOVAL SURGERY. THE PATIENT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18731138 ↗
• InjuryNov 30, 2023Fracture; Fracture

  THE DOCTOR REPORTED THE IMPLANT WAS REMOVED DUE TO IMPLANT FRACTURE APPROXIMATELY 1 YEAR AND 5 MONTHS AFTER IMPLANT PLACEMENT. BONE QUALITY AROUND THE AREA WAS TYPE III, AND ORAL HYGIENE AROUND THE IMPLANT WAS MODERATE. LOCAL INFECTION AND PERI-IMPLANTITIS WERE OBSERVED DURING THE IMPLANT REMOVAL SURGERY. BONE AUGMENTATION MATERIAL WAS USED IN IMPLANT PLACEMENT SURGERY. TRAUMA HISTORY RELATED TO IMPLANT FRACTURE WAS REPORTED. THE PATIENT HAS RECOVERED BUT WILL NEED ANOTHER SURGICAL INTERVENTION.

  Patient problems: Failure of Implant; Inadequate Osseointegration; Unspecified Infection

  MAUDE report 18242868 ↗
• InjuryMar 19, 2020Fracture; Fracture

  THE DENTAL IMPLANT GFX3011S WAS REMOVED ON (B)(6) 2020 DUE TO A FRACTURE OF THE IMPLANT 3 YEARS AND 1 MONTH AFTER IMPLANTATION. THE PATIENT HAS HISTORY OF CARDIAC DISEASE AND COMPROMISED IMMUNITY. THE PATIENT REQUIRED BONE AUGMENTATION FOR THE OPERATION. THE PATIENT HAS RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 9857395 ↗
• InjuryJan 8, 2018Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT GFX3011S WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AFTER THE IMPLANTATION DATE. THE PATIENT HAS HISTORY OF VITAMIN D DEFICIENCY AND HAS BEEN WILL NEED FURTHER SURGICAL INTERVENTION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7172268 ↗
• InjuryNov 13, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT (B)(4) WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 3 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT BONE QUALITY MAY HAVE CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7025338 ↗
• InjuryOct 12, 2017Break; Break

  THE DENTAL IMPLANT GFX3011S BROKE DURING IMPLANTATION. THE DENTAL IMPLANT WAS REMOVED. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Failure of Implant

  MAUDE report 6945513 ↗
• InjuryOct 12, 2017Break; Break

  THE DENTAL IMPLANT GFX3011S BROKE ON IMPLANTATION AND WAS REMOVED FROM THE IMPLANT SITE. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATION.

  Patient problems: Failure of Implant

  MAUDE report 6945457 ↗
• InjuryOct 12, 2017Failure to Osseointegrate; Osseointegration Problem; Failure to Osseointegrate; Osseointegration Problem

  THE DENTAL IMPLANT GFX3011S WAS REMOVED ON (B)(6) 2017 DUE TO FAILURE TO OSSEOINTEGRATE 5 MONTHS AFTER IMPLANTATION. THE DOCTOR INDICATED THAT LOCAL INFECTION AT THE SITE OF THE IMPLANT CAUSED THE IMPLANT REMOVAL. THE PATIENT HAS NO SIGNIFICANT MEDICAL HISTORY AND HAS BEEN RECOVERED WITHOUT COMPLICATIONS.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 6945263 ↗