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CERTAIN® EP® IWTH573Recalls & reported problems

ZimVie US Corp LLC · CERTAIN® EP® HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 3MM(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 00844868009269), received between Aug 9, 2022 and Aug 12, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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

  • Unintended Movement2

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.

  • MalfunctionAug 12, 2022Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THE PATIENT WAS MISSING A HEALING ABUTMENT DURING A IMPLANT STABILITY TEST. IT IS UNKNOWN WHEN IT BECAME MISSING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15221619 ↗
  • InjuryAug 9, 2022Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THE PATIENT LOST THE HEALING ABUTMENT ON THE IMPLANT. DENTIST ATTEMPTED TO REPLACE THE HEALING ABUTMENT AND THE IMPLANT CAME OUT. THE SITE WAS DEBRIDED. TOOTH LOCATION #18 (UNIVERSAL).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15191094 ↗

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.