OSSEOTITE® CERTAIN® IOSM310Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® IMPLANT 3.25 X 10MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844868007029), received between Feb 15, 2021 and Mar 25, 2026 — classified as 6 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 Problem6
Patient problems
- Osteolysis4
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bacterial Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE SECOND IMPLANTS AT TOOTH SITES #19 AND #20.
Patient problems: Osteolysis
MAUDE report 24689447 ↗InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS SEVERE BONE LOSS AROUND THE SECOND IMPLANTS AT TOOTH SITES #19 AND #20.
Patient problems: Osteolysis
MAUDE report 24689286 ↗InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED EARLY BONE LOSS, REMOVED AND BONE GRAFTED. TOOTH SITE: 19.
Patient problems: Osteolysis
MAUDE report 21729557 ↗InjurySep 23, 2024Adverse 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 20278272 ↗InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO LOSS OF BONE. REPLACED WITH ANOTHER ONE. TOOTH #13.
Patient problems: Unspecified Infection
MAUDE report 18862776 ↗InjuryFeb 15, 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 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. BONE LOSS IS ALSO REPORTED. ADDITIONAL APPOINTMENT REQUIRED: YES, TO PLACE A NEW IMPLANT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Unspecified Infection
MAUDE report 11326910 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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