3i T3® DCD® BNST611Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® NON-PLATFORM SWITCHED TAPERED IMPLANT 6 X 11.5MM · Class 2 · Implant
All models of 3i T3 DCD (73)
Data updated Oct 18, 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 00844868029359), received between Sep 24, 2021 and Nov 8, 2023 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Pain2
- Unspecified Infection2
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT DEVELOPED PERI-IMPLANTITIS, REMOVED IMPLANT, PLACED BONE GRAFT, WILL SEE HIKE BACK IN 3-4 MONTHS FOR NEW IMPLANT. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVED IMPLANT, BONE GRAFT. ADDITIONAL APPOINTMENT REQUIRED: YES. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 18096638 ↗InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT WAS IN PAIN FOR A LONG TIME, IMPLANT WAS REMOVED. TOOTH SITE # 19. PATIENT IS FEELING MUCH BETTER, WILL TRY AGAIN IN 5 MONTHS. SYMPTOMS: PAIN.
Patient problems: Pain
MAUDE report 13939487 ↗InjurySep 24, 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 AN INFECTION. THE PATIENT DEVELOPED INFECTION IN AREA IN CONJUNCTION W/ SINUS AUGMENTATION. HAD TO REMOVE IMPLANT.
Patient problems: Unspecified Infection
MAUDE report 12527390 ↗
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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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