T3 T3PT4310Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Tapered Implant 4/3mm (D) X 10mm (L) · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie T3 PRO tapered dental implant is a root-form screw placed in the jawbone to replace a tooth. The 61 reports mostly describe implants that failed to heal in and had to be taken back out, often because of infection or bone loss around the site, along with pain, swelling and pus drainage. No deaths and 60 injuries were reported. 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
- 63
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00844868046714), received between Mar 8, 2023 and Sep 29, 2026 — classified as 62 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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. 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 Problem62
- Patient-Device Incompatibility1
- Unsealed Device Packaging1
Patient problems
- Osteolysis36
- Unspecified Infection35
- Pain14
- Inflammation11
- Erosion7
- Swelling/ Edema4
- Discomfort2
- Nerve Damage2
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Osteolysis
MAUDE report 50932303 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to an infection at tooth site 13.Inflammation, pain and swelling reported as a consequence.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 50784122 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that implant #30 was placed on (b)(6) 2026, along with implants #29 and #27. On (b)(6) 2026, the patient presented for a final check and X-ray, which revealed bone loss and infection around implant #30. The patient returned on (b)(6) 2026 for the removal of implant #30. The area was bone grafted again, and a re-do of implant #30 will be attempted in 3+ months.No impact on the patient reported.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 50751088 ↗InjuryJun 12, 2026Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITE #29 WAS REMOVED DUE TO INFECTION & BONE LOSS AND ALLERGIC REACTION. POSSIBLE ALLERGIC REACTION OR PATIENT'S BODY REJECTING IMPLANTS. POST-OP VISIT 2 FOR ZIMVIE BIOMET 3I DENTAL IMPLANT 29 T3PT4310 TIGHT TO 50 NCM AND ENCODE HEALING ABUTMENT IEEHA353. PATIENT DOING WELL AND USED MEDICATIONS (CEFDINIR) AS PRESCRIBED. MILD REDNESS 31-M BUT NO GINGIVAL SWELLING. BOTH HEALING ABUTMENTS MOBILE AND PAIN TO TWISTING. PERIAPICAL RADIOGRAPH LR AND SHOWS RADIOLUCENCY ALL AROUND THE DENTAL IMPLANT. APPEARS PATIENT REJECTING THE DENTAL IMPLANT OR COULD HAVE HAD AN INFECTION. PATIENT HAS TITANIUM JOINT REPLACEMENTS WITH NO PROBLEMS. SHE KNOWS OF NO METAL ALLERGIES. EXPLAINED TO PATIENT DENTAL IMPLANT NEEDS TO BE REMOVED AND BONE GRAFTING OF THE RIDGE NEEDED AGAIN. I SHOWED PATIENT THE POST-OP RADIOGRAPH ON (B)(6) 2026 AND HOW GOOD THE BONE LOOKED AND HOW IT HAS RESORBED SINCE THEN. SYMPTOMS / PATIENT IMPACT: PAIN, SWELLING.
Patient problems: Hypersensitivity/Allergic reaction; Osteolysis; Unspecified Infection
MAUDE report 25484386 ↗InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DISCOVERED DURING CLINICAL PROCEDURE. WILL REPLACE IMPLANT IN 4 MONTHS. SYMPTOMS / PATIENT IMPACT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 25219732 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #33 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24799937 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 24769418 ↗InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #29 DEVELOPED A BUBBLE OVER THE SITE AND WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24604091 ↗InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #13 WAS REMOVED DUE TO BONE LOSS. FAILED INTEGRATION, MOBILITY, DISCOMFORT. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Discomfort; Osteolysis; Pain
MAUDE report 24519299 ↗InjuryMar 2, 2026Adverse 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 24485959 ↗InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Erosion; Pain; Swelling/ Edema
MAUDE report 24283328 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THERE WAS POOR BONE QUALITY AROUND THE IMPLANT AT TOOTH SITE #4. THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24267649 ↗InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #5 WAS REMOVED DUE TO PERI-IMPLANTITIS. 7.5 WEEKS AFTER IMPLANT PLACEMENT PATIENT BEGAN HAVING PAIN AND SWELLING AT THE IMPLANT SITESYMPTOMS AS A RESULT OF THE EVENT: EDEMA; INFLAMMATION; PAIN & SWELLING.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24233055 ↗InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FINAL EXAMINATION OF THE IMPLANT AT TOOTH SITE #4. IT WAS NOTED THAT THERE WAS SIGNIFICANT BONE LOSS AT THE SITE. TWO WEEKS PRIOR, THE PATIENT WAS EXAMINED AND IT WAS NOTED THAT THE IMPLANT LOOKED GOOD AT THAT TIME. IT WAS NOTED THAT THE BONE LOSS PREVENTED INTEGRATION AND WAS NOT STABLE. THE PATIENT WAS SCHEDULED FOR REMOVAL OF THE IMPLANT.
Patient problems: Osteolysis
MAUDE report 23977723 ↗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 #20 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23868944 ↗InjuryDec 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 #35 WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23797449 ↗InjuryDec 11, 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 #11 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23783545 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED BONE LOSS ON TOOTH SITE # 4 AND THE IMPLANT FAILED. AN ADDITIONAL APPOINTMENT WAS REQUIRED TO REPLACE THE IMPLANT.
Patient problems: Osteolysis
MAUDE report 23305846 ↗InjuryAug 29, 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: Bruxism; Osteolysis
MAUDE report 22922549 ↗InjuryAug 4, 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: Erosion; Pain; Unspecified Infection
MAUDE report 22701679 ↗InjuryAug 4, 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 #29 AND #30 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, PAIN, INFLAMMATION, AND ABSCESS.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 22701430 ↗InjuryJul 30, 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 22669669 ↗InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER #44 FAILED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22553548 ↗InjuryJun 19, 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 #4 AND #11 WERE REMOVED DUE TO PERI-IMPLANTITIS. ABNORMAL BONE TO IMPLANT CONTACT AT #4 AND #11 WITH PERI-IMPLANT RADIOLUCENCY SEEN ON BOTH #4 AND #11 DEPRESSIBLE FAILED TO INTEGRATE. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 22293512 ↗InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AT FOLLOW-UP, THE PATIENT HAD PAIN AND PRESSURE AROUND THE IMPLANT AT TOOTH LOCATION #4. THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND PRESSURE.
Patient problems: Osteolysis; Pain
MAUDE report 22202979 ↗
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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