T3 T3ST510Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 10mm (L) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie T3 PRO dental implant is a screw-shaped root implant placed in the jawbone. The 27 reports mostly describe implants that loosened or were lost to bone loss and infection around the implant (peri-implantitis), with26 injuries and no deaths; many mention removal of the implant, along with pain, inflammation and swelling. There are 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
- 27
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00844868046967), received between Jun 8, 2023 and Aug 17, 2026 — classified as 26 injuries, 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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 Problem26
- Mechanical Problem1
Patient problems
- Osteolysis21
- Unspecified Infection18
- Inflammation5
- Pain5
- Discomfort2
- Bone Fracture(s)1
- Erosion1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 31 was loose due to bone loss and subsequently was removed.
Patient problems: Osteolysis
MAUDE report 50273941 ↗InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN AN UNKNOWN DENTAL POSITION FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 25110946 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #29 AND #30 WERE REMOVED DUE TO BONE LOSS ASSOCIATED WITH PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24987489 ↗InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND DISCOMFORT.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 24570719 ↗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 BEFORE THE SURGERY.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24392637 ↗InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT TOOK ANTIBIOTICS BEFORE THE SURGERY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24389294 ↗InjuryDec 19, 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 FAILED DUE TO PERI-IMPLANTITIS. IMPLANT PLACED WITH SINUS LIFT PERFORMED. IMPLANT REMOVED PRIOR TO BE LOADED. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23854105 ↗InjuryNov 18, 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
MAUDE report 23586905 ↗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 #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Erosion; Pain; Unspecified Infection
MAUDE report 23547465 ↗InjuryNov 7, 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. PERFORMED RESCUE PROCEDURE TO DEBRIDE IMPLANT, CT SCAN AFTER 3 MONTHS REVEALED BONE LOSS. REMOVED IMPLANT. GRAFTED SITE AGAIN. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23501262 ↗MalfunctionOct 20, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE IMPLANT CONNECTION WAS DAMAGED. IMPOSSIBLE TO PLACE AN ABUTMENT. IMPLANT REMOVED AND REPLACED. TOOTH LOCATION 47. BONE TYPE I.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23334698 ↗InjurySep 2, 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 SORE, GOT LOOSE AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22946027 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD RECEIVED TWO COURSES OF ANTIBIOTIC THERAPY DUE TO PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #31 WITHOUT ANY IMPROVEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22063551 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD RECEIVED TWO COURSES OF ANTIBIOTIC THERAPY DUE TO PERI-IMPLANTITIS AROUND THE IMPLANT AT TOOTH LOCATION #31 WITHOUT ANY IMPROVEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22063506 ↗InjuryMay 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 #20 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND SWELLING.
Patient problems: Unspecified Infection
MAUDE report 22059605 ↗InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED LOOSEN AND BONE LOSS OF THE IMPLANT AFTER PROSTHESIS. DOCTOR ALSO REPORTED BONE FRACTURE AT TOOTH SITE 36. IMPLANT WAS REMOVED.
Patient problems: Bone Fracture(s); Osteolysis
MAUDE report 21983738 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO HAVE THE IMPLANT AT TOOTH LOCATION #31 RESTORED BECAUSE OF REPEATED PERI-IMPLANTITIS. THEY FEEL THAT IT WAS RELATED TO BONE LOSS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21961830 ↗InjuryFeb 24, 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 #18 WAS REMOVED DUE TO BONE LOSS & INFECTION. DEBRIDEMENT WAS DONE AFTER THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21446452 ↗InjuryJan 6, 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.
Patient problems: Osteolysis
MAUDE report 21078673 ↗InjuryNov 21, 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 AND INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20754215 ↗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 #19 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 20599573 ↗InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE CLINICIAN THAT THE IMPLANT IN SITE #3 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19797701 ↗InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BONE LOSS, TOOTH # 15. SYMPTOMS AS A RESULT OF THE EVENT, INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19627884 ↗InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT BECAME PAINFUL AFTER PROCEDURE. TOOTH # 14.
Patient problems: Pain
MAUDE report 18319413 ↗InjuryNov 16, 2023Adverse 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: Unspecified Infection
MAUDE report 18156966 ↗
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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 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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