CERTAIN® ILPC343URecalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H) · Class 2 · Implant
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00844868021094), received between Mar 1, 2021 and May 29, 2026 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (12 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
- Fracture12
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENTS FRACTURED BY THE SCREW PART AND WERE REMOVED. ABUTMENTS WERE PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. NO IMPACT ON THE PATIENT REPORTED. TOOTH LOCATION # 25+26. BONE DENSITY TYPE: IV
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330884 ↗MalfunctionMay 29, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENTS FRACTURED BY THE SCREW PART AND WERE REMOVED. ABUTMENTS WERE PLACED ON (B)(6) 2026 AND REMOVED ON (B)(6) 2026. NO IMAPACT ON THE PATIENT REPORTED. TOOTH LOCATION # 25+26. BONE DENSITY TYPE: IV.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330741 ↗MalfunctionMay 11, 2026Fracture
IT WAS REPORTED THAT THE MULTI UNIT ABUTMENT SCREWS FRACTURED. THE CLINICIAN WAS TRYING TO SCREW THE SCANBODY FOR TAKING IMPRESSIONS AND THE ABUTMENTS CAME TOGETHER. THE FRACTURED PART OF THE SCREW WAS REMOVED. TOOTH LOCATION 23 AND 13.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134426 ↗MalfunctionJul 1, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22369515 ↗MalfunctionMar 7, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21544953 ↗MalfunctionJul 15, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19739070 ↗MalfunctionMay 25, 2023Fracture; Fracture
THE DOCTOR REPORTED THAT THE LOW PROFILE ABUTMENT BROKE ON THE SCREW PART IN THE PATIENT'S MOUTH AND THEREFORE REMOVED IT. THE AFFECTED DENTAL POSITION IS #34. THE DOCTOR INDICATED IN THE PER THAT THE PROCEDURE WAS CONCLUDED WITH THE PLACEMENT OF ANOTHER LOW PROFILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17003651 ↗MalfunctionApr 18, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760018 ↗MalfunctionApr 18, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16760001 ↗MalfunctionApr 13, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16731852 ↗InjuryMay 14, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11824231 ↗MalfunctionMar 1, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11391865 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- 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.