3i T3® DCD® BNSS311Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 3.25 X 11.5MM · Class 2 · Implant
All models of 3i T3 DCD (73)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868028987), received between Feb 1, 2021 and May 9, 2025 — classified as 3 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 Problem3
Patient problems
- Pain3
- Unspecified Infection3
- Inflammation2
- Osteolysis2
- Abscess1
- Discomfort1
- Edema1
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 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 #10 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, DISCOMFORT AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21996919 ↗InjuryApr 28, 2021Adverse 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 AND BONE LOSS WITH INFLAMMATION, PAIN AND DISCOMFORT. PATIENT WILL RETURN FOR A NEW IMPLANT IN THE FUTURE. TOOTH #7.
Patient problems: Discomfort; Inflammation; Osteolysis; Pain; Unspecified Infection
MAUDE report 11737330 ↗InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTS THAT THE BNSS311 IMPLANT WAS REMOVED DUE TO INFECTION AND BONE LOSS. TOOTH LOCATION # 23. ABSCESS, EDEMA, INFLAMMATION AND PAIN ARE ALSO REPORTED. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.
Patient problems: Abscess; Edema; Inflammation; No Code Available; Pain; Unspecified Infection
MAUDE report 11257760 ↗
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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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