OSSEOTITE® CERTAIN® 2 XIFOSS485Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868023203), received between Nov 22, 2019 and May 13, 2026 — classified as 7 injuries.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 25159607 ↗
• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS MOBILE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ASPIRATION, PARESTHESIA AND EDEMA.

  Patient problems: Aspiration/Inhalation; Osteolysis; Unspecified Infection

  MAUDE report 25159521 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 44 WAS REMOVED DURING UNCOVERING DUE TO PERI-IMPLANTITIS. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: Osteolysis; Pain; Unspecified Infection

  MAUDE report 20628093 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DURING IMPLANT SURGERY DUE TO LACK OF PRIMARY STABILITY. NEW APPOINTMENT WOULD BE REQUIRED TO PLACE NEW IMPLANT.

  Patient problems: No Code Available

  MAUDE report 10725035 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANT (XIFOSS485) WAS REMOVED DUE TO INFECTION AT TOOTH LOCATION 21.

  Patient problems: Unspecified Infection

  MAUDE report 10524620 ↗
• InjuryApr 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT XIFOSS485 LACKED PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED. PATIENT WILL HAVE TO GO BACK TO THE PRACTICE TO PLACE A NEW IMPLANT. DENTAL SITE 13.

  Patient problems: No Information

  MAUDE report 9994895 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. THE PATIENT ALSO EXPERIENCED ABCESS. TOOTH LOCATION 37.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 9364632 ↗