CERTAIN® ILPC441URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) · Class 2 · Implant
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00844868021070), received between Aug 9, 2021 and Sep 30, 2026 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Fracture” (9 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
- Fracture9
- Separation Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
It was reported that the abutment fractured at the screw part. Abutment placed on (b)(6) 2026 and removed on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945475 ↗InjuryNov 17, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23568477 ↗MalfunctionJul 11, 2025Fracture; Fracture
IT WAS REPORTED THAT TWO DENTAL ABUTMENTS FRACTURED BY THE SCREW. NO IMPACT ON THE PATIENT WAS REPORTED. PROCESS COMPLETED WITH OTHER ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476844 ↗MalfunctionJul 1, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT ONE ABUTMENT FRACTURED AT THE SCREW AREA AND WAS REMOVED. PROCEDURE WAS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369905 ↗MalfunctionNov 15, 2024Separation Problem; Separation Problem
THE ABUTMENTS HAVE UNSCREWED AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695481 ↗MalfunctionNov 15, 2024Separation Problem; Separation Problem
THE ABUTMENTS HAVE UNSCREWED AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695356 ↗MalfunctionDec 11, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18301582 ↗MalfunctionAug 2, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446458 ↗MalfunctionAug 2, 2023Fracture; Fracture
DOCTOR REPORTED SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446249 ↗MalfunctionAug 12, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12311715 ↗MalfunctionAug 9, 2021Fracture; Fracture
DOCTOR REPORTED THAT THE ABUTMENT AND SCREW FRACTURED. THE DOCTOR CONFIRMS THAT THE PROCEDURE WAS COMPLETED WITH OTHER INSTRUMENTS AND THAT THE PATIENT DID NOT SUFFER ANY NEGATIVE IMPACT ON HIS HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12292510 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.