3i T3® BOST685Recalls & reported problems
ZimVie US Corp LLC · 3i T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 6 X 8.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00844868029748), received between Nov 19, 2020 and Apr 6, 2026 — classified as 16 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
Patient problems
- Osteolysis12
- Pain4
- Unspecified Infection4
- Inadequate Osseointegration1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
- No Information1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO BONE LOSS AND IMPLANT MOBILITY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24792867 ↗InjurySep 10, 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. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 23020292 ↗InjuryMay 27, 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.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22090074 ↗InjuryApr 23, 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 #30 SUFFERED FROM BONE LOSS. REMOVAL OF IMPLANTS WITH GRAFTING.
Patient problems: Osteolysis
MAUDE report 19162919 ↗InjuryApr 22, 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 #18 WAS REMOVED DUE TO BONE LOSS. PATIENT CAME IN COMPLAINING THAT THE RESTORED IMPLANT HAD BEEN BOTHERSOME FOR QUITE SOME TIME. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 16792724 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT SITE WAS BONE GRAFTED, DUE TO BONE LOSS. TOOTH SITE #19 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Osteolysis
MAUDE report 15352578 ↗InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT SITE WAS BONE GRAFTED, DUE TO BONE LOSS. TOOTH SITE #19 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Osteolysis
MAUDE report 15352531 ↗InjuryAug 30, 2022Adverse 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 # 19 (UNIVERSAL). THE SITE WAS GRAFTED WITH ALLOGRAFT TOGETHER WITH ORIGINAL IMPLANT PLACEMENT.
Patient problems: Osteolysis
MAUDE report 15319783 ↗InjuryApr 15, 2022Adverse 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 INFECTION AT THE IMPLANT SITE.
Patient problems: Osteolysis
MAUDE report 14117548 ↗InjuryFeb 1, 2022Adverse 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: Osteolysis; Unspecified Infection
MAUDE report 13416388 ↗InjuryOct 8, 2021Adverse 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 WITH A LOSS OF INTEGRATION. PATIENT WILL NOT RETURN FOR ADDITIONAL APPOINTMENTS. TOOTH #31.
Patient problems: Inadequate Osseointegration; Osteolysis; Unspecified Infection
MAUDE report 12598788 ↗InjurySep 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED LACK OF PRIMARY STABILITY AT TOOTH SITE 16. TM CONFIRMED BY PHONE ON (B)(6) 2021 THAT NO OTHER IMPLANT WAS PLACED TO FINISH THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12553299 ↗InjuryMay 13, 2021Adverse 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
MAUDE report 11821543 ↗InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT LOST INTEGRATION DUE TO SIGNIFICANT BONE LOSS AT THE IMPLANT SITE AND WAS REMOVED. PERI IMPLANTITIS WAS ALSO NOTED AND THE PATIENT WAS GIVEN AMOXICILLIN.
Patient problems: No Code Available; Pain
MAUDE report 11284865 ↗InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AFTER ATTEMPTING TO SUBMERGE THE IMPLANT, IT WAS UNABLE TO BE PLACED DUE TO A LACK OF PRIMARY STABILITY. IT WAS NOT INDICATED IF THE PATIENT WOULD RETURN FOR A NEW IMPLANT. TOOTH #16.
Patient problems: No Information
MAUDE report 11258715 ↗InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION 14.
Patient problems: Unspecified Infection
MAUDE report 10872181 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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