CERTAIN® ILPC341Recalls & reported problems
ZimVie US Corp LLC · CERTAIN® LOW PROFILE ABUTMENT 3.4MM(D) X 1MM(H) · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844868021162), received between Nov 5, 2020 and Mar 18, 2025 — classified as 1 injury, 1 malfunction.
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 Conditions1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2025Fracture; Fracture
DOCTOR REPORTED THAT THEY INSERTED THE MULTI-UNIT AT TOOTH SITE 14, THEY SCREWED ON THE ABUTMENT AND THE ABUTMENT FRACTURED AT THE SCREW PART. A LITTLE PIECE GOT STUCK IN THE IMPLANT ((B)(6), LOT NUMBER: 2017011134), BUT COULD BE REMOVED AFTER A WHILE. THIS LITTLE PIECE WENT LOST DURING THE PROCESS. THE IMPLANT HAD BEEN PLACED LONG AGO. IT STAYED IN THE PATIENT¿S MOUTH AND SEEMED NOT DAMAGED ANY FURTHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21633153 ↗InjuryNov 5, 2020Fracture; Fracture
DOCTOR REPORTED THE SCREW FRACTURED AND REMOVED.
Patient problems: No Information
MAUDE report 10790830 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.