Eztetic™ CT3111Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
Quick summary
This Eztetic CT3111 is a root-form endosseous dental implant used as a tooth replacement anchor. The 72 reports mostly describe infection around the implant, bone loss (osteolysis), pain, and inflammation, with several implants fractured, shifted, or positioned too close to a neighbor and removed; 69 reports describe injuries and no deaths. 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
- 70
- Deaths reported
- 0
- Injuries reported
- 67
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00889024343887), received between Sep 17, 2019 and Apr 28, 2026 — classified as 67 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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 Problem61
- Fracture7
- Migration1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection39
- Osteolysis36
- Pain19
- Inflammation13
- No Clinical Signs, Symptoms or Conditions9
- Swelling/ Edema5
- Fistula2
- No Code Available2
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 WAS REMOVED DUE TO INFECTION AROUND THE IMPLANT AFTER PLACEMENT. AN ADDITIONAL APPOINTMENT WAS REQUIRED.
Patient problems: Unspecified Infection
MAUDE report 25018937 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Bone Fracture(s)
MAUDE report 24442807 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER IMPLANT. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 24118373 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION 25 FRACTURED AND WAS REMOVED. ANOTHER IMPLANT PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24065285 ↗InjuryJul 28, 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 #14 AND #15 WERE REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22632507 ↗InjuryJul 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 #41 WAS TOO CLOSE TO THE IMPLANT AT TOOTH SITE #42 AND WOULD NOT ALLOW FOR PROPER RESTORATION. THE IMPLANT AT TOOTH SITE #41 WAS REMOVED AND A NEW IMPLANT WAS PLACED IN A BETTER POSITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22580513 ↗InjuryJun 25, 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: Pain
MAUDE report 22333543 ↗InjuryJun 25, 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. IMPLANT SHOWED EARLY SIGNS OF PERI-IMPLANT DISEASE AND WAS REMOVED. TOOTH #7. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 22331955 ↗InjuryMar 27, 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 #5 AND #7 WERE REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 21712983 ↗InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT SEEN IN OFFICE TO HAVE IMPLANT # 12 REMOVED DUE TO BONE LOSS. PATIENT WILL TRANSITION TO A REGULAR DENTURE. NO OTHER PROCEDURES NEEDED, NO BONE GRAFT.
Patient problems: Osteolysis
MAUDE report 21020177 ↗InjuryNov 8, 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: Pain
MAUDE report 20637389 ↗InjuryOct 1, 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: Erosion; Pain; Unspecified Infection
MAUDE report 20348161 ↗InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 20301098 ↗InjurySep 19, 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: Inflammation; Osteolysis
MAUDE report 20255238 ↗InjurySep 5, 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: Inflammation; Unspecified Infection
MAUDE report 20152085 ↗InjuryAug 22, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 20041944 ↗InjuryAug 18, 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 #20 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19999058 ↗InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT IS REPORTED THAT THE IMPLANT AT TOOTH SITE #1.2 WAS PLACED IMMEDIATELY AFTER EXTRACTION OF TOOTH, GOOD PRIMARY STABILITY, GRAFT WAS PLACED IN THE GAP, TORQUE 30NCM, 6 MONTHS AFTER PLACEMENT THERE WAS A FISTULA DISCOVERED, AND PERI-IMPLANTITIS ON BOTH SITES, VESTIBULAR BONE LOSS, IMPLANTS ARE THEN REMOVED AND SITES ARE GRAFTED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS. INFLAMMATION.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19839269 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT AT TOOTH LOCATION # 11 PLACED AT ANOTHER OFFICE IN (B)(6) 2023. BEFORE THAT, THE TOOTH WAS REMOVED AND NO BONE GRAFT WAS PLACED. THE PATIENT WAS SEEN FOR PAIN AND SWELLING AROUND THE IMPLANT AT SITE # 11. THE IMPLANT REMAINED IMPLANTED AND THE PATIENT WAS GIVEN AMOXICILLIN DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19613924 ↗InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SEEN AGAIN AFTER BEING PRESCRIBED ANTIBIOTICS. THE IMPLANT AT TOOTH LOCATION #11 REMAINED IMPLANTED AND THE AREA AROUND THE IMPLANT WAS DEBRIDED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19574374 ↗InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD THE IMPLANT AT TOOTH LOCATION #11 PLACED AT ANOTHER OFFICE IN JULY 2023. BEFORE THAT, THE TOOTH WAS REMOVED AND NO BONE GRAFT WAS PLACED. THE PATIENT WAS SEEN FOR PAIN AND SWELLING AROUND THE IMPLANT AT SITE #11. THE IMPLANT REMAINED IMPLANTED AND THE PATIENT WAS GIVEN AMOXICILLIN DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19574216 ↗InjuryJun 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS SEEN WITH COMPLAINTS OF PAIN AND SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #11. THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN. SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 19574086 ↗InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BONE LOSS AND INFECTION. TOOTH #11.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19515390 ↗InjuryMay 17, 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 #29 SUFFERED FROM A BONE LOSS. BONE RESORPTION-APICAL HALF OF IMPLANT.
Patient problems: Osteolysis
MAUDE report 19344911 ↗InjuryMay 13, 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: Osteolysis
MAUDE report 19306992 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.