T3 T3ST610Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 10mm (L) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00844868047018), received between Aug 2, 2023 and May 18, 2026 — classified as 8 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 Problem8
Patient problems
- Unspecified Infection7
- Osteolysis4
- Erosion1
- Inflammation1
- Pain1
- Sinus Perforation1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND INFECTION. PATIENT PRESENTED WITH INFECTION WHICH AFFECTED IMPLANT. COMPLETE PERI IMPLANT, BONE LOSS. REMOVED IMPLANT AND WILL GRAFT IN FUTURE. NOTED INFECTION, BONE LOSS, PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25209041 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT UN-COVERY, SIGNIFICANT BONE LOSS WAS OBSERVED AROUND THE IMPLANT AT TOOTH SITE #14. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25018928 ↗InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO INFECTION. THE PATIENT EXPERIENCED DISCOMFORT FOR TWO WEEKS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 23547200 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Sinus Perforation
MAUDE report 23393238 ↗InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS / PATIENT IMPACT: ABSCESS, INFLAMMATION, PAIN.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 22057246 ↗InjuryMar 14, 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 BONE LOSS. DISCOVERED TO HAVE SIGNIFICATE BONE LOSS AT UNCOVERY. REMOVED AND GRAFTED.
Patient problems: Unspecified Infection
MAUDE report 21604554 ↗InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BONE LOSS AND INFECTION AT IMPLANT TOOTH SITE #14. THERE WAS SPONTANEOUS AVULSION OF THE IMPLANT > 4 MONTHS; THEREFORE, IT WAS REMOVED AND GRAFTED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18341256 ↗InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION # 31 FAILED DUE TO PERI-IMPLANTITIS. THE SITE WAS CLEANED AND WILL LET IT HEAL FOR FUTURE IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17446211 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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