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LOCATOR 07351Recalls & reported problems

Zest Anchors, LLC · LOCATOR Small Diameter Implant x 2.5mm · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840481101601), received between Oct 12, 2021 and Jan 31, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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

  • Failure to Osseointegrate1
  • Fracture1

Patient problems

  • Failure of Implant1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 31, 2023Fracture; Fracture

    FRACTURE. DOCTOR REPORTED THAT AFTER INSERTION OF IMPLANT, I WENT TO FIX THE LOCATOR OF IMPLANT SCREW. DURING THIS PROCESS THE SCREW FROM THE IMPLANT WAS BROKEN AND I HAD TO CHANGE THE COMPLETE IMPLANT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16272105 ↗
  • InjuryOct 12, 2021Failure to Osseointegrate; Failure to Osseointegrate

    FAILED TO INTEGRATE. DOCTOR CONFIRMED BY EMAIL ON 30 SEP 2021 THAT LOCATOR ATTACHMENT GOT LOOSE, THEY THINK THAT THIS IS DUE TO DAMAGE THREADS.

    Patient problems: Failure of Implant

    MAUDE report 12619215 ↗

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.