3i T3® BOPT4311Recalls & reported problems
ZimVie US Corp LLC · 3i T3® TAPERED IMPLANT 4/3 X 11.5MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie 3i T3 dental implant is a root-form implant placed into bone. Most of the 125 reports describe infection or bone loss around the implant, and some say the implant was removed. The reports include no deaths and 124 injuries. Reports fell to 11 in the last 12 months from 25 in the previous 12. 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
- 127
- Deaths reported
- 0
- Injuries reported
- 126
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00844868028475), received between Sep 16, 2019 and Sep 17, 2026 — classified as 126 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (3 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 Problem118
- Fracture3
- Patient-Device Incompatibility2
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
- Mechanical Problem1
- Separation Failure1
Patient problems
- Unspecified Infection75
- Osteolysis63
- No Clinical Signs, Symptoms or Conditions18
- Pain18
- Inflammation17
- No Information10
- Abscess8
- No Code Available5
Recent adverse event reports
The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to a Peri-implantitis. Tooth site 5.Bone density type: II.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50798484 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Doctor reported that implant was removed due to Peri-implantitis with abscess, it sat loosely at implant site 14. Patient has been rescheduled for reimplantation.
Patient problems: Abscess; Osteolysis; Unspecified Infection
MAUDE report 50752629 ↗InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. NO IMPACT ON THE PATIENT REPORTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25191003 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #28 WAS WELL INTEGRATED BUT HAD UNACCEPTABLE CRESTAL BONE LOSS. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 25154135 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # UNKNOWN WAS REMOVED DUE TO A BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24887721 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION WAS NOT PROVIDED.
Patient problems: Unspecified Infection
MAUDE report 24887116 ↗InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24886988 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24835883 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24835433 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 26 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24830256 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 37 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24829842 ↗InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24093338 ↗InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WITH CRESTAL FISTULAS OVER COVER SCREW. EXPLORED AND IMPLANT LOOSE WITH BONE RESORPTION.
Patient problems: Fistula
MAUDE report 23863429 ↗InjuryAug 28, 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 #11 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22911526 ↗InjuryJun 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 #12 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22134323 ↗InjuryMay 20, 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 #7 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 22056859 ↗InjuryMay 7, 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 PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21980466 ↗InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD 7MM POCKETING DEPTH SURROUNDING THE IMPLANT AT TOOTH SITE #19 AND REMOVAL WAS SUGGESTED. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21979872 ↗InjuryApr 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT PATIENT HAD TITANIUM ALLERGY, FAILED 3 MON AFTER PLACEMENT. TOOTH 5. IMPLANT WAS REMOVED. ADDITIONAL APPOINTMENT REQUIRED FOR RIDGE AUGMENTATION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21806021 ↗InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS TREATED FOR INFECTION TOOTH #8. PATIENT STARTED TO HAVE PAIN WITH THE IMPLANT AROUND 2 WEEKS AFTER PLACEMENT. PATIENT FELT THE TEMPORARY CROWN WAS LOOSE. PATIENT STARTED ANTIBIOTIC METRONIDAZOLE AND CESDINIR ON (B)(6) 2025. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 21746044 ↗InjuryApr 1, 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 PERIIMPLANTITIS. PAIN, NON-INTEGRATION BONE LOSS TOOTH #8. PATIENT STARTED TO HAVE PAIN WITH THE IMPLANT AROUND 2 WEEKS AFTER PLACEMENT. PATIENT FELT THE TEMPORARY CROWN WAS LOOSE. PATIENT STARTED DOUBLE ABX 3 DAYS AGO PT WAS TOLD ON (B)(6) 2025 THE IMPLANT HAD FAILED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21740246 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD IMPLANT #13 PLACED (B)(6) 2024. HAD GOTTEN INFECTION AFTER SURGERY. PATIENT STATED IT FELL OUT ON (B)(6) 2024 AND HAD PAIN 2-3 DAYS BEFORE IT FELL OUT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 21723994 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERI-IMPLANTITIS ONE AND A HALF YEAR AFTER IMPLANTATION AT TOOTH SITE 45 OBSERVED DURING THE CLINICAL PROCEDURE, AND THE IMPLANT WAS REMOVED. PAIN AND INFLAMMATION WERE REPORTED AS A RESULT OF THE EVENT. AN ADDITIONAL APPOINTMENT WAS REQUIRED 6 MONTHS AFTER THE EVENT DATE. BONE GRAFT WAS PERFORMED.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21707114 ↗InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 33 WAS REMOVED DUE TO PERI-IMPLANTITIS. DISCOMFORT AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Discomfort; Osteolysis; Unspecified Infection
MAUDE report 21698880 ↗InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT #47 BECAME MOBILE AND WAS REMOVED DUE TO PERI IMPLANTITIS. PATIENT FELT PAIN AND SITE HAD INFLAMMATION AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21545595 ↗
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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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