Eztetic™ CM3111Recalls & reported problems
ZimVie US Corp LLC · Class 2 · Implant
All models of Eztetic (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Eztetic CM3111 root-form dental implant by ZimVie is a screw-shaped implant used to replace a missing tooth. The 64 reports mostly describe implants that became infected or lost support in the jaw bone, with pus drainage, abscess, pain and swelling, and several implants having to be removed; 61 reports involved injuries and no deaths were reported. Reports dropped from 10 in the earlier 12 months to 2 in the most recent 12 months. 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
- 65
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00889024343597), received between Sep 24, 2019 and Sep 14, 2026 — classified as 62 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem61
- Component Missing2
- Fracture2
Patient problems
- Unspecified Infection41
- Osteolysis32
- Pain20
- Inflammation13
- No Code Available7
- No Clinical Signs, Symptoms or Conditions6
- No Information5
- Abscess3
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that an implant was removed due to an infection at tooth site 28. Patient suffered from inflammation and tenderness.Bone density type: II.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50750877 ↗InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #23 GOT INFECTED WITH PUS DRAINAGE. THE IMPLANT ALSO LOST INTEGRATION AND WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS, INFLAMMATION, PAIN AND SWELLING.
Patient problems: Osteolysis; Purulent Discharge; Unspecified Infection
MAUDE report 25359277 ↗InjuryDec 3, 2025Adverse 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 SITE # 32. PATIENT HAD ABSCESS, AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 23708081 ↗InjuryOct 30, 2025Adverse 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 23430023 ↗InjuryOct 30, 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 #32-33-34 WERE REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 23429968 ↗InjuryOct 30, 2025Adverse 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 23429890 ↗InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT WHEN THE CLINICIAN PLACED THE IMPLANT AT TOOTH LOCATION #12, THE BUCCAL PLATE FRACTURED. THE IMPLANT WAS REMOVED.
Patient problems: Bone Fracture(s)
MAUDE report 23050751 ↗InjurySep 4, 2025Adverse 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: Pain
MAUDE report 22961355 ↗InjuryMay 16, 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 #6 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 22039394 ↗InjuryApr 24, 2025Adverse 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 BONE LOSS. TOOTH SITE # 33.
Patient problems: Osteolysis
MAUDE report 21898191 ↗InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS BECAME MOBILE AFTER 2 YEARS AND WERE REMOVED DUE TO PERI IMPLANTITIS. INFLAMMATION, PAIN AND EDEMA WERE REPORTED AS A RESULT OF THE EVENT. PROCEDURE NOT COMPLETED.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 21536724 ↗InjuryDec 6, 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 #9 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20867908 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REPORTED THAT IMPLANT AT TOOTH SITE 35 WAS REMOVED DUE TO BONE LOSS. IMPLANT WAS PLACED ON NARROW CREST AT 30 N AND WITH POLISHED COLLAR AT MARGINAL BONE LEVEL. IN THE NEXT CHECK UPS DOCTOR NOTICED IN THE X-RAY MARGINAL BONE LOSS OF MORE THAN 3 MM.
Patient problems: Osteolysis
MAUDE report 20732466 ↗InjuryOct 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 #26 WAS REMOVED DUE TO BONE LOSS & INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 20480946 ↗InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH 22 AND 23 WERE REMOVED DUE TO PERI-IMPLANTITIS. INFLAMMATION AND DEHISCENCE WERE REPORTED AS A RESULT OF THE EVENT.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 20343913 ↗MalfunctionSep 27, 2024Fracture; Fracture
IT WAS REPORTED A FRACTURE OF THE IMPLANT BODY DURING PLACEMENT AT TOOTH SITE 12 AND IMPLANT WAS REMOVED. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20319909 ↗InjuryAug 22, 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; Pain; Unspecified Infection
MAUDE report 20038750 ↗InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT BUCCAL BONE LOSS WAS FOUND AROUND THE IMPLANT AT TOOTH LOCATION #10. THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis
MAUDE report 20026956 ↗InjuryJul 19, 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 #10 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19783165 ↗InjuryJul 15, 2024Fracture; Fracture
DOCTOR REPORTED IMPLANT FRACTURE #12. PROCEDURE COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Osteolysis
MAUDE report 19738283 ↗InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO BONE LOSS. PAIN WAS REPORTED AS A RESULT OF THE EVENT. PATIENT HAD TO RETURN TO COMPLETE THE PROCEDURE.
Patient problems: Osteolysis; Pain
MAUDE report 19203664 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PERIIMPLANTITIS AT TOOTH SITE #24. PATIENT SUFFERED AN ABSCESS. IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19012832 ↗InjuryMar 20, 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; Unspecified Infection
MAUDE report 18941964 ↗InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #10 LOST INTEGRATION DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE AND WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18409615 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERI-IMPLANTITIS AT IMPLANT TOOTH SITE #10. THEREFORE, THE IMPLANT WAS REMOVED.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 18284546 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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