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CERTAIN® IIIC41Recalls & reported problems

ZimVie US Corp LLC · CERTAIN® PICK-UP COPING 4.1MM(D) X 4.1MM(P) · Class 1 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844868005582), received between Jul 21, 2021 and Jul 21, 2021 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #30 & #11 DID NOT INTEGRATE DUE TO LACK OF PRIMARY STABILITY AND WERE REMOVED. THE AREAS WERE GRAFTED AND THE PATIENT IS RETURNING FOR IMPLANT REPLACEMENT AT A LATER DATE.

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

    MAUDE report 12204387 ↗

Other ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS devices

All ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS devices →

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