CERTAIN® ILPAC3417Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE 17° ABUTMENT 3.4MM(D) X 4MM(H) · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868037545), received between May 4, 2021 and Jun 13, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2025Unintended Movement; Unintended Movement
THE DOCTOR REPORTS THAT THE ABUTMENT ILPAC3417 BECAME LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22200590 ↗MalfunctionAug 2, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A CHECK UP THE DOCTOR NOTICED THAT THE ABUTMENT SCREWS WERE FRACTURED. DOCTOR CLEANED UP THE AREA AND REPLACE THE ABUTMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17446224 ↗MalfunctionMay 4, 2021Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11769506 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.