3i T3® DCD® BNPS5410Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® PARALLEL WALLED IMPLANT 5/4 X 10MM · 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 00844868028291), received between Nov 21, 2021 and May 15, 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Osteolysis2
- Unspecified Infection2
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 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 #(B)(6) FAILED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 16936043 ↗InjuryOct 20, 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: Unspecified Infection
MAUDE report 15638382 ↗InjuryMar 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 PERI-IMPLANTITIS WITH BONE LOSS AND INFECTION. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 13773077 ↗InjuryNov 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS UNABLE TO BE PLACED DUE TO A LACK OF PRIMARY STABILITY. IMPLANT WAS REMOVED AND A NEW ONE WILL BE PLACED AT THE SITE IN THE FUTURE. TOOTH #19.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12849909 ↗
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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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