T3 T3ST615Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 15mm (L) · 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 00844868047049), received between Dec 1, 2023 and Oct 21, 2025 — 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
- Osteolysis1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PRIOR TO RESTORATION, PATIENT EXPERIENCED SWELLING AND INFECTION WITH IMPLANT. BONE GRAFT EXTENDED 10MM OM DF. REMOVED AND GRAFTED. WILL REPLACE IN 3 MONTHS. PER INDICATED: SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, REVISION IMPLANT. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23353570 ↗InjuryDec 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT IMPLANT TOOTH SITE #19, WITH ASSOCIATED PAIN. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18244152 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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