OSSEOTITE® CERTAIN® INT685Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 6 X 8.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868006787), received between Oct 25, 2019 and Sep 18, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- No Information2
- Osteolysis2
- Unspecified Infection2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20246177 ↗InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT FAILED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20244536 ↗InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT COULD NOT BE PLACED INTO THE BONE AND SPUN. NO OTHER IMPLANT WAS PLACED DURING THE SAME PROCEDURE.
Patient problems: No Information
MAUDE report 9322266 ↗InjuryOct 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT THEY WERE UNABLE TO ACHIEVE PRIMARY STABILITY FOR IMPLANT INT685 IN TOOTH SITE #14. SITE WAS BONE GRAFTED AND PATIENT SENT HOME TO HEAL.
Patient problems: No Information
MAUDE report 9238988 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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