OSSEOTITE® FNT410Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® TAPERED IMPLANT 4 X 10MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite FNT410 is a small tapered endosseous dental implant used as a tooth root replacement. Most of its 57 reports describe implants that failed to fuse with the jaw bone, often because of peri-implantitis, and had to be removed, with patients reporting pain, infection, and bone loss around the implant. There were no deaths, 56 injuries, and 1 mechanical problem; no recalls name this device. Reports rose from 3 in the prior 12 months to 14 in the most recent 12.
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
- 56
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00844868003328), received between Nov 8, 2019 and Apr 14, 2026 — classified as 55 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (4 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem50
- Loss of Osseointegration4
- Patient-Device Incompatibility2
- Detachment of Device or Device Component1
- Fracture1
- Mechanical Problem1
- No Pressure1
Patient problems
- Unspecified Infection43
- Osteolysis33
- Pain14
- Inflammation11
- No Information5
- No Clinical Signs, Symptoms or Conditions3
- No Code Available3
- Abscess2
Recent adverse event reports
The 25 most recent of 56 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,22,24 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN .
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24871696 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,22,24 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN .
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24871624 ↗InjuryApr 13, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16,17, 22, 24, 26, 27 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24855502 ↗InjuryApr 13, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16,17, 22, 24, 26, 27 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24855088 ↗InjuryApr 13, 2026Loss of Osseointegration; No Pressure
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16,17, 22, 24, 26, 27 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24855002 ↗InjuryApr 13, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16,17, 22, 24, 26, 27 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24854880 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16, 22,24, 26 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24853650 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 12,14,16, 22, 24, 26 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AND WERE REMOVED. PATIENT REFERRED PAIN AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24853633 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 12 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24496685 ↗InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46 AND #47 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24056753 ↗InjuryDec 19, 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 #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND EDEMA.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23852086 ↗InjuryDec 4, 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 #16 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23717845 ↗InjuryNov 14, 2025Adverse 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: Bone Fracture(s); Inflammation; Pain
MAUDE report 23553781 ↗InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 26. IMPLANT WAS REMOVED. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT. IMPACT REPORTED ON THE PATIENT: ABSCESS, INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22165562 ↗InjuryJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS AT TOOTH SITE 46 ALONG WITH IMPLANT LOOSENING AND IMPLANT WAS REMOVED. SYMPTOMS REPORTED ON THE PATIENT: INFLAMMATION. THE PROCESS WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21240425 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING EYE IRRITATION, RESPIRATORY TRACT IRRITATION AND LUNG DISEASE. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21197004 ↗InjuryMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER FOLLOW UP, DOCTOR CONFIRMED THAT DURING IMPLANT PLACEMENT, IT DISENGAGE FROM THE MOUNT AND FELL ON PATIENT FACE. PATIENT WOULD HAVE TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19358307 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 14, 12, 22, 24, 32, 43 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19298988 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 14, 12, 22, 24, 32, 43 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19298933 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 16, 14, 12, 22, 24, 32, 43 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19298800 ↗InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 34, 36, 37, 45, 46, 47 WERE REMOVED DUE TO PERI-IMPLANTITIS WITH ABSCESS. PATIENT REFERRED PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 19296589 ↗InjuryMay 10, 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 37 36 35 46 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : INFLAMMATION + SMOKER + ABSCESS + POOR ORAL HYGIENE.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19287630 ↗InjuryMay 10, 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 32 42 34 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : SMOKER + POOR ORAL HIGYENE + ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19286648 ↗InjuryMay 10, 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 32 42 34 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : SMOKER + POOR ORAL HIGYENE + ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19286499 ↗InjuryMay 10, 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 32 42 34 & 44 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: III. THE DOCTOR REPORTED : SMOKER + POOR ORAL HIGYENE + ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19286407 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page