3i T3® BOST3211Recalls & reported problems
ZimVie US Corp LLC · 3i T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This 3i T3 dental implant is a tapered implant placed in the jawbone to support a replacement tooth. Many of the 162 reports describe infection, bone loss and inflammation around the implant, which was often removed. The reports include no deaths and 159 injuries, and reports fell to 7 in the last 12 months from 20 before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 161
- Deaths reported
- 0
- Injuries reported
- 158
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00844868028888), received between Sep 16, 2019 and Jun 2, 2026 — classified as 158 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem155
- Component Missing2
- Mechanical Problem2
- Fracture1
- Separation Failure1
Patient problems
- Unspecified Infection118
- Osteolysis82
- Inflammation41
- Pain41
- Abscess18
- No Clinical Signs, Symptoms or Conditions15
- Swelling/ Edema13
- No Information5
Recent adverse event reports
The 25 most recent of 161 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WERE GINGIVAL SWELLING AND MOBILITY AROUND THE IMPLANT AT TOOTH SITE #12 ONE (1) MONTH AFTER PLACEMENT. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25365518 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 25306044 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #12 AND #23 WERE REMOVED DUE TO INFECTION. THE PATIENT DID NOT BRUSH THE SURGICAL SITES DESPITE THE INSTRUCTIONS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Unspecified Infection
MAUDE report 24802489 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #32 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: MOBILITY AND PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24674080 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #21 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 24523813 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. THE PROCEDURE WAS NOT COMPLETED BY PLACING OTHER IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 24007028 ↗InjuryOct 31, 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: Unspecified Infection
MAUDE report 23441038 ↗InjuryJun 19, 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. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 22293838 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #24. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WAS REMOVED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22209353 ↗InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PERI-IMPLANTITIS. PATIENT REPORTED APPLIANCE LOOSE, NEVER RETURNED FOR MAINTENANCE AFTER DELIVERY IN 2020. IMPLANT WAS LOOSE AND REMOVED BY HAND. DEGRANULATED INFECTED SITE. TOOTH 5. SYMPTOMS AS A RESULT OF THE EVENT: LOSS OF INTEGRATION, INFECTION, BONE LOSS, LOOSENING, NON-INTEGRATION, PAIN, EDEMA, INFLAMMATION. SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THERE A DELAY DURING THE PROCEDURE: NO. ADDITIONAL APPOINTMENT REQUIRED: YES, ADDITIONAL IMPLANT PLACEMENT AND RESTORE WITH NEW HYBRID. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22072286 ↗InjuryMay 21, 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 BONE LOSS. TOOTH SITE # 12.
Patient problems: Osteolysis
MAUDE report 22065494 ↗InjuryMay 21, 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 PERI-IMPLANTITIS. TOOTH SITE # 12. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22060301 ↗InjuryMay 21, 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 PERI-IMPLANTITIS. BONE LOSS. TOOTH SITE # 23.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22060103 ↗InjuryMay 20, 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 PERI-IMPLANTITIS. TOOTH SITE # 24. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22056144 ↗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 #24 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND ABSCESS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22052066 ↗InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS, INFLAMMATION, PAIN AND SWELLING WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22019544 ↗InjuryMay 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22018895 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE # 11. IMPLANT WAS REMOVED. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. PROCEDURE WAS COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21924469 ↗InjuryApr 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH SITE #16. NO IMPACT ON THE PATIENT REPORTED. IMPLANT WAS COMPLETELY REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21750401 ↗InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS APICAL RADIOLUCENCY PRESENT AROUND THE IMPLANT AT TOOTH LOCATION #28. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis
MAUDE report 21712979 ↗InjuryMar 27, 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 #26 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Osteolysis
MAUDE report 21710781 ↗InjuryMar 18, 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 INFECTION. PATIENT PRESENTED FOR A POST-OP. IMPLANT WAS MOBILE AND SUPPURATION PRESENT. PATIENT RETURNED FOR IMPLANT REMOVAL AND BONE GRAFT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 21629748 ↗InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 22 WAS REMOVED DUE TO INFECTION. INFLAMMATION AND PAIN WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 21616617 ↗InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21571253 ↗InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #31 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21195625 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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