OSSEOTITE® CERTAIN® XIFNT585Recalls & reported problems
ZimVie US Corp LLC · OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 8.5MM · Class 2 · Implant
All models of OSSEOTITE CERTAIN (74)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite Certain dental implant, a root-form screw placed in the jawbone, has 56 adverse event reports with no deaths and 55 injuries. Most reports describe implants later removed after infection around the implant, bone loss, swelling, pain, or the implant becoming loose, with several describing it stripped or damaged. Report numbers have eased slightly in the last 12 months, from 14 to 10. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00844868022046), received between Oct 30, 2019 and Jun 9, 2026 — classified as 54 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 Problem54
- Mechanical Problem1
Patient problems
- Unspecified Infection36
- Osteolysis35
- Inflammation8
- Pain8
- Swelling/ Edema6
- No Information5
- No Clinical Signs, Symptoms or Conditions3
- Erosion2
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25446582 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #27 WAS REMOVED DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24963441 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24443993 ↗InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS, INFECTION. PERFECT SURGICAL PLACEMENT, SUNK IN BONE PERFECT, FLUSH, TIGHT, PATIENT RETURNED FOR GUM SWELLING, PA SHOWED INFECTION. IMPLANT MOBILITY THOUGHT OTHER IMPLANT SUCCEEDING, BUT 1 MONTH LATER MOBILITY. TOOTH # 18. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA AND INFLAMMATION.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24412526 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 24339605 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 24211577 ↗InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WENT TO THE GENERAL DENTIST FOR DELIVERY OF DENTURE FOR LOCATOR DENTURE AND STARTED TO COMPLAINT OF PAIN WITH IMPLANT AT TOOTH SITE #29. THE PATIENT WAS SENT TO OUR OFFICE FOR EVALUATION OF THE IMPLANT. PATIENT HAD PAIN AND THE IMPLANT WAS MOBILE. THE IMPLANT WAS REMOVED A FEW DAYS LATER AND A NEW IMPLANT WAS PLACED JUST SLIGHTLY MORE POSTERIOR TO THE FAILED IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Pain
MAUDE report 24187775 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. PERI-IMPLANTITIS, 100% BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24060863 ↗InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS. OSI WAS MOBILE DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23988856 ↗InjuryAug 15, 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 #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND PAIN.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22814132 ↗InjuryMay 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22120488 ↗InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 AND #30 WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22080935 ↗InjuryMay 22, 2025Adverse 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 SITE # 25. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 22073698 ↗InjuryMay 22, 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 #14 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22069201 ↗InjuryMay 18, 2025Adverse 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. TOOTH SITE # 7.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22041367 ↗InjuryApr 18, 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 #18 WAS REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21866205 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT REMOVED DUE TO PERI IMPLANTITIS. TOOTH LOCATION 17.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21750260 ↗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 21650973 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. #14 WAS EXTRACTED AND BONE GRAFTED. NEW IMPLANT PLACED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21643351 ↗InjuryMar 3, 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; Unspecified Infection
MAUDE report 21503860 ↗InjuryJan 14, 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 #21 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 21152198 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #47. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20794279 ↗InjuryNov 8, 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: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20642202 ↗InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PERI IMPLANTITIS OF IMPLANT #17 SEEN ON THE X-RAYS, SO IMPLANT WAS REMOVED. SYMPTOMS: PAIN AND MOBILITY.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20521139 ↗InjurySep 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED A PERI-IMPLANTITIS AND THE IMPLANT WAS REMOVED. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 20255197 ↗
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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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