3i T3® BOPS4315Recalls & reported problems
ZimVie US Corp LLC · 3i T3® PARALLEL WALLED IMPLANT 4/3 X 15MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868029755), received between Jan 2, 2024 and Jan 8, 2024 — classified as 2 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 Problem2
Patient problems
- Unspecified Infection2
- Bone Fracture(s)1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED INFECTION AND LOWER JAW FRACTURE AT TOOTH SITE 44. DOCTOR ALSO REPORTED MASSIVE OSTEOPOROSIS. UPON FOLLOW UP MADE BY EMAIL ON 16 APR 2024 DOCTOR CONFIRMED THAT BONE FRACTURE HAPPENED DUE TO A BIKE ACCIDENT. BONE DENSITY IS NORMAL. AFTER THE ACCIDENT THE CYST AND THE NECROTIC BONES WERE REMOVED, ROUGHENED AND BLEEDING ALLOWED, NONE BONE SUBSTITUTE MATERIAL WAS USED. PATIENT DOES NOT WISH ANY OTHER SURGERIES, A BRIDGE WILL BE MADE
Patient problems: Bone Fracture(s); Unspecified Infection
MAUDE report 18463665 ↗InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED INFECTION WITH PAIN AT TOOTH SITE 22.
Patient problems: Pain; Unspecified Infection
MAUDE report 18426905 ↗
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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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