OSSEOTITE® CERTAIN® XIFNT611Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868022060), received between Oct 29, 2020 and Jul 31, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FIVE MONTHS, SIGNIFICANT BONE LOSS WAS NOTED AROUND THE IMPLANT AT TOOTH SITE #19. THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis

  MAUDE report 22678623 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO SEVERE PERI-IMPLANTITIS.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 21983164 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420000 ↗
• InjuryNov 6, 2024Unintended Movement; Unintended Movement

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621034 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CLINICIAN REMOVED SITE 3 IMPLANT DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, INFECTION . SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE NEW IMPLANT . WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE? NO. SITE GRAFTED: ALLOGRAFT (B)(6) 2011.

  Patient problems: Erosion; Inflammation; Unspecified Infection

  MAUDE report 18428667 ↗
• InjurySep 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF IMPLANT SALVAGE PROCEDURE IN THE PAST (CAPTURED IN ZIMMER BIOMET COMPLAINT NUMBER (B)(4)). THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #30, WITH ASSOCIATED ABSCESS AND INFLAMMATION. THE INFECTION RETURNED AND PRESENTED BONE LOSS. THEREFORE, THE IMPLANT WAS REMOVED.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 17835062 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED A HISTORY OF IMPLANT SALVAGE PROCEDURE ON THE IMPLANT AT TOOTH LOCATION #30 WHICH INCLUDED DEBRIDEMENT AND BONE GRAFTING OF THE DEFECT. THE PATIENT WAS ALSO PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 17773793 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Inflammation; Osteolysis; Pain

  MAUDE report 16405020 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 31 DID NOT ACHIEVE PRIMARY STABILITY DURING PLACEMENT AND WAS REMOVED. A BONE GRAFT WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751827 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTS THAT THE XIFNT611 IMPLANT WAS REMOVED DUE TO BONE LOSS. TOOTH LOCATION # 30 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT AT TIME OF ORIGINAL PLACEMENT.

  Patient problems: Osteolysis

  MAUDE report 11787530 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 3 DUE TO AN INFECTION WAS REMOVED. LARGE AMOUNT OF PLAQUE AND CALCULUS AROUND THE IMPLANT AND TEETH, ORAL HYGIENE IS POOR. SUPPURATION AND INFECTION AROUND THE IMPLANTS AND THE SINUS. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10757011 ↗