T3 T3ST3210Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 3.25mm (D) X 10mm (L) · Class 2 · Implant
Quick summary
This is a ZimVie T3 PRO dental implant, a small titanium screw-shaped device placed in the jaw to replace a tooth. The 37 reports mostly describe implants that failed to heal in or became surrounded by infection and bone loss, so they had to be taken back out, with patients reporting pain, swelling and inflammation;35 reports involved injuries and no deaths were reported. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00844868046868), received between Mar 22, 2023 and Mar 31, 2026 — classified as 32 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 Problem29
- Fracture2
- Failure to Osseointegrate1
- Mechanical Problem1
- Positioning Failure1
- Separation Failure1
Patient problems
- Osteolysis20
- Unspecified Infection18
- Pain6
- Inflammation5
- No Clinical Signs, Symptoms or Conditions5
- Swelling/ Edema3
- Erosion2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #6 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24746176 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 25 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. PAIN, EDEMA AND INFLAMMATION WERE REPORTED AS A CONSEQUENCE OF THE EVENT.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24616861 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24562591 ↗InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 23401961 ↗InjuryAug 28, 2025Separation Failure; Separation Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910669 ↗InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT STAGE 2, A PA RADIOGRAPH REVEALED BONE LOSS & FISTULA AROUND THE IMPLANT AT TOOTH SITE #29. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Fistula; Osteolysis; Unspecified Infection
MAUDE report 22861770 ↗InjuryJun 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #11 AND #12 WERE REMOVED DUE TO FRACTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain
MAUDE report 22320567 ↗InjuryJun 24, 2025Fracture; Fracture
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #11 AND #12 WERE REMOVED DUE TO FRACTURE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22320374 ↗InjuryMay 19, 2025Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem; Failure to Osseointegrate; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A NON INTEGRATION DUE TO A SINUS PERFORATION ALONG WITH INFECTION AND BONE LOSS AT TOOTH SITE 26. IMPLANT WAS LOCATED INTO SINUS AND LATER REMOVED, AFTER 4 MONTHS. INFECTION DETECTED AROUND IMPLANT BEFORE LOADING IT. IMPLANT WAS REMOVED. SYMPTOMS REPORTED ON THE PATIENT: INFLAMMATION AND PAIN
Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection
MAUDE report 22042419 ↗InjuryFeb 25, 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 #12 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21459066 ↗InjuryFeb 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 SITE #9 WAS REMOVED DUE TO BONE LOSS. BONE LOSS DISCOVERED DURING UNCOVERING PROCEDURE.
Patient problems: Osteolysis
MAUDE report 21437741 ↗InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #20, #22, #24, #26 & #29 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21434048 ↗InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #20, #22, #24, #26 & #29 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, PAIN AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21434031 ↗InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #34 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21100037 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANTS AT TOOTH SITES 26, 46 WERE REMOVED DURING UNCOVERING DUE TO PER-IMPLANTITIS WITH INFLAMMATION AND ABSCESS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 21065737 ↗MalfunctionDec 14, 2024Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20932578 ↗InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES 35,36,37 WERE REMOVED DUE TO INFECTION. INFLAMMATION AND PAIN REPORTED AS A CONSEQUENCE OF THE EVENT. OTHER IMPLANT PLACED ON (B)(6) 2024.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 20901833 ↗InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Necrosis; Osteolysis; Unspecified Infection
MAUDE report 20876876 ↗InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Zonular Dehiscence
MAUDE report 20817505 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED CT GUIDED IMPLANT - 2ND STAGE - WAS INFECTED AND DID NOT INTEGRATE. NO SYMPTOM, CAME OUT AT THE TIME OF UNCOVERING. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: YES, REMOVED IMPLANT AND GRAFTED. ADDITIONAL APPOINTMENT REQUIRED: YES, REDO IN 4 MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 20732215 ↗InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #7 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 20599340 ↗MalfunctionSep 12, 2024Mechanical Problem; Mechanical Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200679 ↗InjurySep 10, 2024Adverse 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180572 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD PERSISTENT PAIN AROUND THE IMPLANT AT TOOTH LOCATION #22. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 19961211 ↗InjuryMay 10, 2024Adverse 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 AND INFECTION. A PIECE OF BONE ATTACHED TO THE IMPLANT AT REMOVAL, SURGERY IS ENDED WITH PLACING A GRAFT. TOOTH SITE #4.4 (FDI). SYMPTOMS AS A RESULT OF THE EVENT: PAIN. EDEMA. INFLAMMATION.
Patient problems: Bone Fracture(s); Osteolysis; Unspecified Infection
MAUDE report 19288224 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.