CERTAIN® ILPAC4330Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE 30° ABUTMENT 4.1MM(D) X 3MM(H) · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00844868037613), received between Aug 25, 2021 and Aug 25, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fracture” (7 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
- Fracture7
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inflammation1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 25, 2025Fracture; Fracture
THE DOCTOR REPORTED THAT THE ABUTMENT WAS FRACTURED BY THE SCREW. AFFECTED DENTAL POSITION IS 15. THE PROCEDURE WAS NOT COMPLETED WITH THE PLACEMENT OF ANOTHER ABUTMENT, IMPLANT HAD MOBILITY DUE TO NON INTEGRATION AND WAS REMOVED. THIS EVENT REFLECTS THE ABUTMENT'S FRACTURE SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22881883 ↗MalfunctionJul 1, 2025Fracture; Fracture
THE DOCTOR REPORTS THAT ONE ABUTMENT FRACTURED BY THE SCREW PART. PROCEDURE WAS CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370011 ↗MalfunctionOct 3, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20357415 ↗MalfunctionNov 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 18117906 ↗MalfunctionAug 24, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17610984 ↗MalfunctionAug 1, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17437102 ↗MalfunctionAug 25, 2021Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Pain
MAUDE report 12367657 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- 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.