OSSEOTITE® FNT411Recalls & reported problems
ZimVie US Corp LLC · FULL OSSEOTITE® TAPERED IMPLANT 4 X 11.5MM · Class 2 · Implant
All models of OSSEOTITE (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Osseotite FNT411 is a root-form dental implant used to replace missing teeth. The 54 reports mostly describe implants failing to fuse with the jawbone because of peri-implantitis, with the implant then having to be removed; reports also mention infection around the implant, bone loss, and pain. All 54 involve injuries, with no deaths, and no recalls name this device. Reports in the past 12 months number 17, up from 4 in the prior 12 months.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 00844868003335), received between Aug 29, 2019 and May 7, 2026 — classified as 54 injuries.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem52
- Loss of Osseointegration4
- Fracture2
Patient problems
- Unspecified Infection43
- Osteolysis31
- Pain19
- Inflammation13
- No Code Available5
- No Information3
- Abscess2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED DURING A RUTINARY CHECK-UP IMPLANT AT TOOTH SITE 12 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAS BEEN RESCHEDULED FOR NEW IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25110851 ↗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 24871805 ↗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 24871790 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 36, 42, 44, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND INFLAMMATION. BONE TYPE: III.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24857203 ↗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 24856352 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 36, 42, 44, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND INFLAMMATION. BONE TYPE: III.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24856043 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32, 34, 36, 42,44, 46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND INFLAMMATION. BONE TYPE: III.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24855976 ↗InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANTS AT TOOTH SITE 32,34,36,42,44,46 WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT REFERRED PAIN AND INFLAMMATION. BONE TYPE: III.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24855909 ↗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 24855635 ↗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 24855630 ↗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 24855545 ↗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 24853656 ↗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 24853647 ↗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 24853646 ↗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 24853621 ↗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 24056986 ↗InjuryDec 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 #12 WAS REMOVED DUE TO INFECTION. WAITING FOR HEALING AND BONE REGENERATION FOR NEW IMPLANT PLACEMENT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 23872370 ↗InjuryJun 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #24 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22303554 ↗InjuryJun 6, 2025Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 36.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157146 ↗InjuryApr 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES 34/36 OBSERVED DURING THE CLINICAL PROCEDURE. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21915538 ↗InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERI-IMPLANTITIS AT TOOTH SITES 45/46 OBSERVED DURING THE CLINICAL PROCEDURE. IMPLANT MOBILITY WAS ALSO REPORTED AND IMPLANTS WERE REMOVED. THE PROCESS WAS COMPLETED WITH OTHER IMPLANTS. ADDITIONAL APPOINTMENT WAS REQUIRED: RE-TREATMENT. SYMPTOMS REPORTED ON THE PATIENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21907904 ↗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 19297961 ↗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 19297901 ↗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 19296619 ↗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 12 22 14 & 24 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 19285984 ↗
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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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