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Hex-Lock® ZOA343SRecalls & 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 00889024020757), received between Dec 28, 2020 and Dec 28, 2020 — 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 Information1

Recent adverse event reports

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

  • MalfunctionDec 28, 2020Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT THE SCREW ABUTMENT LOST IST PULL OUT RESISTANCE.

    Patient problems: No Information

    MAUDE report 11076621 ↗

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.