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NA NTAP411Recalls & reported problems

ZimVie US Corp LLC · TAPERED IMPLANT DENSE BONE TAP 4 X 11.5MM · Class 1

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 00844868012221), received between Mar 19, 2023 and Mar 19, 2023 — 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

  • Osteolysis1
  • Pain1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMar 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE IMPLANT ON TOOTH SITE #30 WAS REMOVED DUE TO BONE LOSS AND INFECTION. SYMPTOMS OF THE EVENT: PAIN.

    Patient problems: Osteolysis; Pain; Unspecified Infection

    MAUDE report 16570418 ↗

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.