OSSEOTITE® CERTAIN® IOSS510Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® CERTAIN® IMPLANT 5 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
- 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 00844868007159), received between Nov 11, 2020 and Jul 25, 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
- Unspecified Infection3
- Osteolysis2
- Inflammation1
- No Code Available1
- Pain1
- Swelling/ Edema1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT FAILED DUE TO RAPID BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19829299 ↗InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER # 14 FAILED DUE TO INFECTION. THE DOCTOR REPORTS: IMPLANT PAIN, INFLAMMATION, SWELLING AND EDEMA. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT ON THE SAME DAY.
Patient problems: Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 15074515 ↗InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED PERI-IMPLANTITIS AT TOOTH SITES #26 AND #25. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT IN 3 MONTHS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 14884987 ↗InjuryNov 11, 2020Adverse 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 PERI-IMPLANTITIS.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 10823019 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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