OSSEOTITE® CERTAIN® INT3211Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 3.25 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie dental implant (OSSEOTITE Tapered Certain, a root-form endosseous implant) has 36 adverse event reports naming its identifier, with 35 injuries and no deaths. Reports mostly describe implants needing removal after peri-implantitis, bone loss, infection, or loosening and pain. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00844868006602), received between Oct 18, 2019 and Feb 24, 2026 — classified as 34 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem33
- Mechanical Problem1
- Output Problem1
Patient problems
- Osteolysis24
- Unspecified Infection21
- Pain5
- No Information3
- No Clinical Signs, Symptoms or Conditions2
- Erosion1
- Inflammation1
- No Code Available1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #22 AND #25 WERE REMOVED DUE TO BONE LOSS AND INFECTION. THE PATIENT CAME TO CLINICIAN REFERRING OVERDENTURE MOBILITY AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24429054 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #5 AND #6 WERE REMOVED DUE TO PERI-IMPLANTITIS. THIS WAS NOTE DURING REGULAR EXAMINATIONS. THE IMPLANTS WERE REPLACED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24101177 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 22 AND 25 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24096991 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 22 AND 25 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24096696 ↗InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERIIMPLANTITIS. DENTIST DISCOVERED AT TIME OF DELIVERING CROWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23956366 ↗InjuryDec 16, 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: Osteolysis
MAUDE report 23822433 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain
MAUDE report 23479781 ↗InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23413582 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO "IMPLANTITIS".
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21985468 ↗InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR. REPORTED THAT HE PLACED THE IMPLANT 2 YEARS AGO (2023) AND IT DID NOT HAVE OSSEOINTEGRATION, THE PATIENT REPORTED PAIN SEVERAL TIMES DURING HER CONSULTATION. UPON FOLLOW-UP THE IMPLANT PLACEMENT DATE WAS UPDATED.
Patient problems: Osteolysis
MAUDE report 21880805 ↗InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR. REPORTED THAT HE PLACED THE IMPLANT 2 YEARS AGO (2023) AND IT DID NOT HAVE OSSEOINTEGRATION, THE PATIENT REPORTED PAIN SEVERAL TIMES DURING HER CONSULTATION. UPON FOLLOW-UP THE IMPLANT PLACEMENT DATE WAS UPDATED.
Patient problems: Osteolysis
MAUDE report 21880714 ↗InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED.THE PROCESS WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21650915 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #34 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20344715 ↗InjurySep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis
MAUDE report 20332855 ↗InjurySep 17, 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. TOOTH LOCATION IS UNKNOWN.
Patient problems: Osteolysis
MAUDE report 20237861 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #31 #33 #35 & #39 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: IV.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20026241 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #31 #33 #35 & #39 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: IV.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20015603 ↗InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER #31 #33 #35 & #39 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: IV.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20005345 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS
Patient problems: Erosion; Unspecified Infection
MAUDE report 19619566 ↗InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19490859 ↗InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 12, 15 AND 22 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19049250 ↗InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 13, 18, 21, 23 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 18426455 ↗InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION AND BONE LOSS POST IMPLANT PLACEMENT. THE SITE WAS GRAFTED WITH ALLOGRAFT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 17556242 ↗InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #20 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15805737 ↗InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS NOT USED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14642012 ↗
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- 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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