Eztetic™ CT3113Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Eztetic (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie Eztetic CT3113 is a root-form endosseous dental implant used to replace missing teeth. The 43 reports mostly describe implants that had to be removed because of infection, bone loss, or peri-implantitis, with some also mentioning a fractured implant. Reports describe 42 injuries and no deaths. 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
- 42
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00889024343894), received between Sep 24, 2020 and Jun 5, 2026 — classified as 41 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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 Problem40
- Fracture1
- Mechanical Problem1
Patient problems
- Unspecified Infection24
- Osteolysis19
- Inflammation12
- No Clinical Signs, Symptoms or Conditions5
- Pain5
- Abscess4
- Erosion3
- Swelling/ Edema3
Recent adverse event reports
The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2026Fracture
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #24 FRACTURED AND IT HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25415007 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS. LOOSE IMPLANT. TOOTH NUMBER 13.
Patient problems: Osteolysis
MAUDE report 25072881 ↗InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #11 WAS REMOVED DUE TO INFECTION. PA WAS TAKEN. BONE WAS PLACED. AN ADDITIONAL APPOINTMENT WAS REQUIRED IN APPROXIMATELY FIVE MONTH FOR AN IMPLANT REPLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 24972013 ↗InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 22 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS AND INFLAMMATION.
Patient problems: Erosion; Inflammation; Unspecified Infection
MAUDE report 24011438 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH #25 WAS REMOVED DUE TO PERIIMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 22359446 ↗InjurySep 10, 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: Inflammation; Unspecified Infection
MAUDE report 20179958 ↗InjurySep 9, 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: Osteolysis
MAUDE report 20173843 ↗InjurySep 9, 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: Erosion; Inflammation; Unspecified Infection
MAUDE report 20170658 ↗InjurySep 9, 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: Erosion; Inflammation; Unspecified Infection
MAUDE report 20170460 ↗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: Osteolysis
MAUDE report 20150196 ↗InjuryJul 24, 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 #11(UNIVERSAL) WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN
Patient problems: Pain; Unspecified Infection
MAUDE report 19816037 ↗InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT IN TOOTH SITE #35 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 19315830 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER UNKNOWN X2 & 11 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: I.
Patient problems: Osteolysis
MAUDE report 18993145 ↗InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANTS LOCATED IN DENTAL POSITIONS NUMBER UNKNOWN X2 & 11 FAILED DUE TO BONE LOSS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANTS. BONE TYPE: I.
Patient problems: Osteolysis
MAUDE report 18992176 ↗InjuryMar 8, 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 NERVE INJURY. LOSS INTEGRATION.
Patient problems: Nerve Damage
MAUDE report 18870990 ↗InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 21 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18629086 ↗InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER #31 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. THE DOCTOR REPORTED ABSCESS.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 18132361 ↗InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THE PATIENT WAS REOFFERED TO THE OFFICE FOR REMOVAL OF THE IMPLANT AT TOOTH LOCATION #10 AND EXTRACTION OF MULTIPLE TEETH. A RADIOLUCENCY WAS NOTED ON THE PATIENT'S PERIAPICAL RADIOGRAPH INDICATING INFECTION. IT WAS DECIDED THAT THE IMPLANT WOULD BE REMOVED AT THE TIME OF OTHER EXTRACTIONS.
Patient problems: Unspecified Infection
MAUDE report 17842954 ↗InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DEVELOPED AN INFECTION AND IMPLANT HAD TO BE REMOVED. TOOTH #25. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17625310 ↗InjuryAug 23, 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: Osteolysis; Pain; Unspecified Infection
MAUDE report 17604150 ↗InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #12 WAS REMOVED DUE TO INFECTION. SYMPTOMS OF THE EVENT: PAIN, INFLAMMATION, EDEMA AND ERYTHEMA.
Patient problems: Erythema; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 16096341 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #10 WAS REMOVED DUE TO PERI-IMPLANTITIS. THE PATIENT PRESENTED WITH AN ABSCESS WITH LOCALIZED EDEMA. THE IMPLANT WAS REMOVED, AND THE SITE GRAFTED WITH PUROS.
Patient problems: Abscess; Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 15698024 ↗InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED PERI-IMPLANTITIS. CRESTAL BONE LOSS AND GINGIVAL RECESSION. THE IMPLANT WAS REMOVED. TOOTH SITE #24. THE SITE WAS GRAFTED WITH ALLOGRAFT PRIOR TO ORIGINAL IMPLANT PLACEMENT.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 15506048 ↗InjurySep 9, 2022Adverse 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 INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15391796 ↗
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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 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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