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CERTAIN® ISHA44Recalls & reported problems

ZimVie US Corp LLC · CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) 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 00844868007883), received between Oct 1, 2019 and May 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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.

Most reported problems

Device problems

  • Positioning Failure2

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 6, 2021Positioning Failure; Positioning Failure

    CUSTOMER REPORTED THAT THE HEALING ABUTMENT WOULD NOT SEAT DOWN ALL THE WAY IN THE IMPLANT. IT WAS ABOUT 2MM SITTING OUT OF THE IMPLANT. DOCTOR WAS ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER HEALING ABUTMENT.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 11782647 ↗
  • MalfunctionOct 1, 2019Positioning Failure; Positioning Failure

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Information

    MAUDE report 9142168 ↗

Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices

All ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.