CERTAIN® ILPC444Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ABUTMENT 4.1MM(D) X 4MM(H) · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868021230), received between Oct 9, 2023 and May 14, 2026 — classified as 2 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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Fracture
IT WAS REPORTED THAT THE LOW PROFILE ABUTMENT SCREW FRACTURED WHEN PLACING IT. PROCEDURE NOT COMPLETED. TOOTH LOCATION 26.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25169047 ↗MalfunctionOct 9, 2023Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17900799 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.