3i T3® BOES465Recalls & reported problems
ZimVie US Corp LLC · 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868032496), received between Dec 17, 2021 and Mar 24, 2026 — classified as 5 injuries.
The most frequently reported specific device problem is “Mechanical Problem” (2 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 Problem2
- Mechanical Problem2
- Separation Failure1
Patient problems
- Pain3
- Osteolysis2
- Swelling/ Edema2
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: MOBILITY AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24674525 ↗InjuryMar 31, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46-47 COULD NOT BE PLACED DUE TO ALLEGED THREAD DEFECTS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND AN ADDITIONAL PROCEDURE WAS RECOMMENDED FOR FUTURE IMPLANT PLACEMENTS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, PAIN.
Patient problems: Pain; Swelling/ Edema
MAUDE report 21733630 ↗InjuryMar 31, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #46-47 COULD NOT BE PLACED DUE TO ALLEGED THREAD DEFECTS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND AN ADDITIONAL PROCEDURE WAS RECOMMENDED FOR FUTURE IMPLANT PLACEMENTS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, PAIN.
Patient problems: Pain; Swelling/ Edema
MAUDE report 21732139 ↗InjuryAug 9, 2024Separation Failure; Separation Failure
IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO SEPARATE THE IMPLANT #46 FROM THE MOUNT. PROCEDURE NOT COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950454 ↗InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT AT TOOTH SITE # 30 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13028811 ↗
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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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