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Hex-Lock® ZOA341ARecalls & reported problems

ZimVie US Corp LLC · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024020719), received between Apr 19, 2023 and Apr 19, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

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 Movement1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 19, 2023Unintended Movement; Unintended Movement

    THE DOCTOR REPORTED THAT THE ABUTMENT LOOSENED ABNORMALLY, THE AFFECTED DENTAL POSITION IS 14. THE DOCTOR INDICATES THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER ABUTMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16768467 ↗

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.