CERTAIN® ILPAC4417Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE 17° ABUTMENT 4.1MM(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 00844868037569), received between Nov 6, 2020 and May 16, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
Patient problems
- Inflammation1
- No Clinical Signs, Symptoms or Conditions1
- No Information1
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2024Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Inflammation; Osteolysis
MAUDE report 19333733 ↗MalfunctionNov 11, 2021Fracture; Fracture
DURING FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE SCREW WAS NOT FRACTURED, IT WAS JUST DAMAGED WHILE TRYING TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12800689 ↗MalfunctionNov 6, 2020Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Information
MAUDE report 10801716 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.