3i T3® DCD® BNPT4315Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® TAPERED IMPLANT 4/3 X 15MM · Class 2 · Implant
All models of 3i T3 DCD (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844868029472), received between Jul 6, 2020 and Oct 18, 2023 — classified as 4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Unspecified Infection3
- Osteolysis2
- Inflammation1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #11, WITH ASSOCIATED PAIN, ABSCESS AND INFLAMMATION. THEREFORE, THE IMPLANT IMMEDIATELY FAILED AND WAS REMOVED.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 17956866 ↗InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #26 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 16556415 ↗InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT THE IMPLANTS IN TOOTH SITE #45 AND OTHER UNKNOWN LOCATION WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 12021638 ↗InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT AT TOOTH SITE # 7 WAS REMOVED DUE TO INFECTION. PATIENT TO RETURN FOR REPLACEMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10232537 ↗
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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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