3i T3® BOPT5411Recalls & reported problems
ZimVie US Corp LLC · 3i T3® TAPERED IMPLANT 5/4 X 11.5MM · Class 2 · Implant
Quick summary
This ZimVie 3i T3 dental implant has 106 reports, no deaths and 100 injuries. Many reports describe bone loss around the implant, infection around it, and inflammation, and some describe implants removed because of peri-implantitis, a gum and bone infection around the implant. Reports fell from 18 in the prior 12 months to 5 in the latest 12 months. 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
- 107
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00844868028512), received between Nov 14, 2019 and Jul 29, 2026 — classified as 101 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem99
- Mechanical Problem5
- Device Markings/Labelling Problem1
- Expulsion1
- Fracture1
- Positioning Failure1
- Use of Device Problem1
Patient problems
- Unspecified Infection59
- Osteolysis58
- Inflammation27
- Pain21
- No Clinical Signs, Symptoms or Conditions15
- No Code Available7
- No Information7
- Abscess5
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a peri-implantitis. Tooth site 15.Patient suffered from pain.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50066044 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS. IMPLANT STARTED TO UNDERGO BONE LOSS AND RECESSION ON THE BUCCAL.
Patient problems: Osteolysis
MAUDE report 25219931 ↗MalfunctionMar 24, 2026Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24676458 ↗InjuryJan 13, 2026Adverse 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: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24058967 ↗InjuryJan 8, 2026Adverse 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: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24014032 ↗InjuryDec 17, 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
MAUDE report 23828714 ↗InjurySep 3, 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 # 4 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT WAS PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 22950966 ↗InjuryJul 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: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22644713 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #36. PAIN WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22209739 ↗InjuryJun 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 #37 WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22208425 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #21-23. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22201363 ↗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 #36 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22079444 ↗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 #36 AND #37 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN, INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22079210 ↗InjuryMay 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 #19 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21999483 ↗InjuryApr 23, 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 BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21893217 ↗InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #36 LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21432457 ↗InjuryJan 28, 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: Erosion; Pain; Unspecified Infection
MAUDE report 21252324 ↗MalfunctionJan 22, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21206366 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH LOCATION 45 WAS REMOVED DUE TO PERI IMPLANTITIS. INFLAMMATION REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21196267 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #18 AND #19 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21129912 ↗InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH LOCATIONS #18 AND #19 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21129842 ↗InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT A TOOTH SITE # 3 WAS REMOVED DUE TO BONE LOSS. RESTORATION BECAME LOOSE AND DDS DID NOT FIX.
Patient problems: Osteolysis
MAUDE report 21020664 ↗InjuryNov 20, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20734139 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 47 WAS REMOVED DUE TO PERI-IMPLANTITIS. THERE WAS AN INFLAMMATORY BONE LOSS 20 MONTHS AFTER PROSTHETIC TREATMENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20704023 ↗InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #47 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20565016 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.