CERTAIN® EP® IMHA34Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844868006275), received between Dec 9, 2022 and Jan 9, 2025 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (3 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
- Positioning Failure3
- Fracture1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 9, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112422 ↗MalfunctionJan 9, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112366 ↗MalfunctionJan 9, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112226 ↗InjuryNov 27, 2023Fracture; Fracture
IT WAS REPORTED THAT THE HEALING CAP FRACTURED AT THE TIME OF REPLACING AFTER THE FIXTURE HEAD IMPRESSION WAS TAKEN. THE IMPLANT AT TOOTH LOCATION #12 HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18210061 ↗MalfunctionDec 9, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THE ABUTMENT BECAME LOOSE AND DOCTOR TIGHTENED AND SENT PATIENT HOME. ABUTMENT WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15954788 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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 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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