T3 T3PT5485Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Tapered Implant 5/4mm (D) X 8.5mm (L) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a ZimVie T3 PRO tapered dental implant, a small screw-shaped post placed in the jaw to anchor a replacement tooth. The 37 reports mostly describe implants that loosened or broke down in the bone and had to be removed, along with pain, swelling, and infection around the implant site. These reports include 35 injuries and no deaths. There have been no recalls naming 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
- 40
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00844868046806), received between Dec 6, 2022 and Sep 28, 2026 — classified as 38 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (3 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. 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 Problem36
- Mechanical Problem3
- Patient-Device Incompatibility1
Patient problems
- Osteolysis25
- Unspecified Infection14
- Pain12
- Inflammation4
- Nerve Damage4
- No Clinical Signs, Symptoms or Conditions4
- Swelling/ Edema3
- Paresthesia2
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported peri-implantitis, when switching the cover screw for an encode healing abutment for #19,20 implant, fair amount of granulation was found around both implants and they were loose. Implant had to be removed.This event refers to the peri-implantitis in tooth site 19.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50914383 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis
MAUDE report 50650450 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth #36 was removed due to loss of osseointegration and peri-implantitis. The patient reported pain.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 50034422 ↗InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 LOST INTEGRATION AND WAS REMOVED DUE TO SEVERE LOCALIZED PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25125656 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 WAS REMOVED DUE TO BONE LOSS. TOOTH NUMBER 18. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 25116229 ↗MalfunctionApr 9, 2026Mechanical Problem
THE DOCTOR REPORTS THAT THE IMPLANT AT TOOTH SITE 46 HAS A DAMAGED HEXAGON AND WAS REMOVED. NO NEGATIVE IMPACT ON THE PATIENT¿S HEALTH WAS REPORTED AS A CONSEQUENCE OF THE EVENT. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829853 ↗InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SENT TO OUR OFFICE FROM THE GENERAL DENTIST BECAUSE THE PATIENT FELT LIKE THE CROWN TO THE IMPLANT AT TOOTH SITE #14 NEEDED TO BE TIGHTEN. DURING OUR EXAMINATION, THE PATIENT HAD RADIOLUCENCY AROUND THE IMPLANT. THE IMPLANT HAD FAILED AND WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24815640 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS, AND TO PREVENT FURTHER BONE LOSS FROM OCCURRING. THE IMPLANT WAS PLACED WITH AN INDIRECT SINUS LIFT PROCEDURE. TWO WEEKS LATER, THE AREA WAS SWOLLEN AND PAINFUL. BONE LOSS WAS CONFIRMED VIA X-RAY IMAGING AND THE IMPLANT WAS REMOVED. AN ADDITIONAL PROCEDURE IS ANTICIPATED TO REPLACE THE IMPLANT IN SEVERAL MONTHS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.
Patient problems: Inflammation; Osteolysis; Swelling/ Edema
MAUDE report 24641400 ↗InjuryFeb 20, 2026Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Swelling/ Edema
MAUDE report 24405788 ↗InjuryDec 22, 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 #16 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23867083 ↗InjuryDec 5, 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: Sinus Perforation
MAUDE report 23726260 ↗InjuryNov 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 #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 23644086 ↗InjuryOct 15, 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: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 23306433 ↗InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #19 FAILED AND WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 22506255 ↗InjuryMay 15, 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 # 13 WAS REMOVED DUE TO PERI-IMPLANTITIS. IMPLANT 13 BECAME TENDER AND MOBILE, WITH BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION & PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22027837 ↗InjuryMar 5, 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 #14 WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 21529392 ↗InjuryFeb 26, 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 #29 WAS REMOVED DUE TO AN INFECTION WHICH WAS DISCOVERED DURING RADIOLUCENCY. AFTER IMPLANT REMOVAL THE CUSTOMER WAS TREATED WITH ANTIBIOTICS. SYMPTOMS AS A RESULT OF THE EVENT; ABSCESS.
Patient problems: Erosion; Unspecified Infection
MAUDE report 21471515 ↗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 #14 WAS REMOVED DUE TO SEVERE LOCALIZED PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21439970 ↗InjuryFeb 18, 2025Mechanical Problem; Mechanical Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21394621 ↗InjuryJan 23, 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 HAD AN INFECTION AND HAD TO BE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 21223539 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED NERVE DAMAGE AT TOOTH SITE 46 OBSERVED DURING CLINICAL PROCEDURE. A SHORTER IMPLANT WAS GOING TO BE PLACED DUE TO NERVE PROXIMITY, NEVERTHELESS, THE PATIENT REPORTED HIGH PAIN AND AN ADDITIONAL APPOINTMENT WAS REQUIRED. SYMPTOMS SUFFERED BY THE PATIENT: PARESTHESIA AND PAIN.
Patient problems: Nerve Damage; Pain; Paresthesia
MAUDE report 20703987 ↗InjuryNov 4, 2024Adverse 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20603998 ↗InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS. MOBILITY OF #14 IMPLANT AND PAIN WHEN TORQUING OF THE IMPLANT. NO CLEAR REASON FOR THE FAILURE. HAD TO REMOVE AND DEBRIDE IMPLANT SOCKET.
Patient problems: Osteolysis; Pain
MAUDE report 20464673 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 36 WAS REMOVED DUE TO PERI-IMPLANTITIS. SUPPURATION, EDEMA AND PAIN WERE REPORTED AS A RESULT OF THE EVENT. PATIENT WILL RETURN TO PLACE A NEW IMPLANT.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20344527 ↗InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO INFECTION. INFECTION IN BONE CAUSED IMPLANT TO FAIL. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 20321169 ↗
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 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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