3i T3® BOPT6585Recalls & reported problems
ZimVie US Corp LLC · 3i T3® TAPERED IMPLANT 6/5 X 8.5MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This is a 3i T3 tapered dental implant, a root-form screw placed into the jaw to support a tooth. The 35 reports mostly describe implants that had to be taken out after bone loss around the implant (peri-implantitis), often with infection, inflammation, pain, or an abscess; a few mention implants that loosened, failed to integrate, or whose hex connection broke during surgery. There are no deaths, and all 35 reports are injuries. 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00844868029892), received between Nov 30, 2020 and Jan 8, 2026 — classified as 35 injuries.
The most frequently reported specific device problem is “No Flow” (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 Problem30
- No Flow2
- Expulsion1
- Mechanical Problem1
- Patient-Device Incompatibility1
- Separation Problem1
Patient problems
- Osteolysis27
- Unspecified Infection26
- Inflammation8
- Pain7
- Sinus Perforation3
- Abscess2
- No Clinical Signs, Symptoms or Conditions2
- Neck Pain1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #17 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 24012964 ↗InjuryDec 11, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE HEX OF THE IMPLANT AT TOOTH SITE #18 BECAME DAMAGED DURING SURGERY. THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778137 ↗InjurySep 3, 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 FAILED AND WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain
MAUDE report 22951341 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #15-25. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANTS WERE REMOVED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22220603 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PERIIMPLANTITIS AT TOOTH SITE #15-25. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. IMPLANT WERE REMOVED.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22220273 ↗InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS HAVING LOTS OF PAIN AND SINUS ISSUES. THE DOCTOR AND PATIENT THOUGHT IT WAS BEST TO HAVE THE IMPLANT REMOVED DUE TO PERI-IMPLANTITIS & SINUS PERFORATION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS; INFLAMMATION; PAIN & SWELLING. TOOTH LOCATION IS UNKNOWN.
Patient problems: Osteolysis; Sinus Perforation; Unspecified Infection
MAUDE report 22009207 ↗InjuryMay 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 PERIIMPLANTITIS. PATIENT WENT TO GENERAL DENTIST DUE TO NOTICING CROWN WAS LOOSE. GENERAL DENTIST TRIED TO TIGHTEN CROWN BUT NOTICED ENTIRE IMPLANT WAS LOOSE. PATIENT WAS SEEN (B)(6) 2025 IMPLANT HAD BONE LOSS AND LOST INTEGRATION. IMPLANT WAS REMOVED AND BONE GRAFT ADDED. TOOTH SITE: 14. SYMPTOMS AS A RESULT OF THE EVENT: PAIN INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21979252 ↗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 #27 WAS REMOVED DUE TO PERI-IMPLANTITIS. ABSCESS WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 21195805 ↗InjuryOct 17, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 14 WAS REMOVED DUE TO ALLERGIC REACTION. ALLERGIC TO ALLOY, REMOVAL. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 20476585 ↗InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PT HAD UNCOVER OF IMPLANT APPOINTMENT ON (B)(6) 2024, DR PROCEEDED TO EVALUATE AREA OF IMPLANT TOOTH SITE #3 AND NOTICED THAT PT HAD BONE LOSS AND THE IMPLANT WAS UNSTABLE, UNCOVER OF IMPLANT WAS PUT OFF AND THE IMPLANT WAS THEN REMOVED, BONE GRAFT WAS USED ON THE EXTRACTION SITE FOR A FUTURE IMPLANT PLACEMENT.
Patient problems: Osteolysis
MAUDE report 19392065 ↗InjuryMay 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 #30 WAS REMOVED DUE TO INFECTION AND BONE LOSS THAT SPREAD TO THE IMPLANT SITE AND CAUSED FAILURE.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19332522 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED BISPHOSPHONATES IN (B)(6) 2023 TO TREAT/PREVENT INFECTION/BONE LOSS (PERI-IMPLANTITIS).
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19321861 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE GENERAL DENTIST'S OFFICE FOR A ROUTINE APPOINTMENT WHERE THE IMPLANT AT TOOTH LOCATION #3 FELL OUT. THE IMPLANT LOST INTEGRATION DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19321261 ↗InjuryMay 3, 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 #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19239980 ↗InjuryMar 15, 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 PERI-IMPLANTITIS. TOOTH LOCATION IS UNKNOWN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18916332 ↗InjuryJan 10, 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 16 WAS REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 18482659 ↗InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #18, WITH ASSOCIATED PAIN. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18157099 ↗InjuryNov 13, 2023Expulsion; Expulsion
PATIENT CAME BACK MONTHS LATER IN PAIN, HEADACHE, INFLAMED BONE. TOOTH #19. I WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERIIMPLANTITIS.
Patient problems: Neck Pain; Osteolysis; Unspecified Infection
MAUDE report 18123068 ↗InjuryOct 6, 2023Adverse 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. INFLAMMATION WAS REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO PLACE A NEW IMPLANT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 17884883 ↗InjuryJul 26, 2023No Flow; No Flow
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AND DISCOMFORT, SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT. SITE #3. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17395507 ↗InjuryJul 25, 2023No Flow; Adverse Event Without Identified Device or Use Problem; No Flow; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & INFLAMMATION SITE GRAFTED: ALLOGRAFT.
Patient problems: Osteolysis
MAUDE report 17393299 ↗InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #45 WAS REMOVED DUE TO PERI-IMPLANTITIS. PAIN WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17268511 ↗InjuryApr 12, 2023Adverse 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: Inflammation; Pain; Sinus Perforation; Swelling/ Edema; Unspecified Infection
MAUDE report 16728372 ↗InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED GROSS GRANULATION TISSUE NOTED AT THE IMPLANT SITE AT TOOTH LOCATION #18 AS WELL AS PURULENCE SEEN AT THE TIME OF IMPLANT UNCOVERY. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Abscess; Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 16619025 ↗InjuryFeb 16, 2023Separation Problem; Separation Problem
IT WAS REPORTED THAT DURING RESTORATION, THE PATIENT¿S GENERAL DENTIST USED A NON-ZIMVIE ABUTMENT/SCREW WITH A ZIMVIE IMPLANT WHICH RESULTED IN THE DENTIST FAILING TO COMPLETE THE RESTORATION DUE TO COMPLICATIONS OF THE SCREW USED. THE PATIENT WAS THEN REFERRED BACK TO THE SURGEON TO HAVE THE SCREW REMOVED. TWO ATTEMPTS WERE MADE WITH NO SUCCESS OF REMOVING THE SCREW. THE GENERAL DENTIST WAS ADVISED THAT THEY COULD NOT MOVE FORWARD WITH SEEING THE PATIENT AGAIN TO COMPLETE THE FINAL RESTORATION. THE RECOMMENDATION PROVIDED TO THE PATIENT AS THE ONLY ALTERNATIVE WAS TO HAVE THE WHOLE IMPLANT REMOVED AND UNFORTUNATELY START OVER. THE IMPLANT AT TOOTH LOCATION #14 WAS REMOVED AND THE PATIENT WILL RETURN FOR FUTURE IMPLANT PLACEMENT. NOTE: THE MANUFACTURER OF THE NON-ZIMVIE ABUTMENT/SCREW IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385054 ↗
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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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