T3 T3ST415Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 15mm (L) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868046943), received between Oct 18, 2023 and Feb 19, 2026 — classified as 11 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 Problem11
Patient problems
- Unspecified Infection10
- Inflammation7
- Osteolysis7
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM INFLAMMATION AND TOOK ANTIBIOTICS BEFORE THE SURGERY.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24392327 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM INFLAMMATION AND TOOK ANTIBIOTICS BEFORE THE SURGERY.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24391680 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. PATIENT SUFFERED FROM INFLAMMATION AND TOOK ANTIBIOTICS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24388878 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD INFLAMMATION AND TOOK ANTIBIOTICS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24376313 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO PERI-IMPLANTITIS. PATIENT HAD INFLAMMATION AND TOOK ANTIBIOTICS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24376080 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 BECAME MOBILE AND WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24304006 ↗InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO ADVANCED (60%) BONE LOSS #12 IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 23568587 ↗InjuryAug 2, 2025Adverse 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. TOOTH SITE #34.
Patient problems: Unspecified Infection
MAUDE report 22693800 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE AREA AROUND THE IMPLANT AT TOOTH LOCATION #24 GOT INFECTED AND LOOSE. THE IMPLANT HAD TO REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20854477 ↗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 #8, WITH ASSOCIATED PAIN AND INFLAMMATION. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Unspecified Infection
MAUDE report 18244202 ↗InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PATIENT EXPERIENCED ACUTE INFECTION AFFECTING IMPLANT. REMOVED AND GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Unspecified Infection
MAUDE report 17959098 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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