3i T3® DCD® BNSS485Recalls & reported problems
ZimVie US Corp LLC · 3i T3® WITH DCD® NON-PLATFORM SWITCHED PARALLEL WALLED IMPLANT 4 X 8.5MM · 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 00844868029083), received between Dec 29, 2020 and May 26, 2022 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 16, 2026.
Most reported problems
Device problems
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hypersensitivity/Allergic reaction2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
DOCTOR REPORTED THAT IMPLANTS HAD TO BE REMOVED DUE TO ALLERGIC REACTION. PROCEDURE DELAYED 6 MONTHS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 14514318 ↗InjuryMay 26, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
DOCTOR REPORTED THAT IMPLANTS HAD TO BE REMOVED DUE TO ALLERGIC REACTION. PROCEDURE DELAYED 6 MONTHS.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 14513915 ↗InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT DID NOT ACHIEVE PRIMARY STABILITY WHEN PLACING AND IT WAS REMOVED.
Patient problems: No Information
MAUDE report 11086735 ↗
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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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