LOCATOR Overdenture Implant System 07457Recalls & reported problems

Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.4mmD x 14mmL, 4mm Cuff · Class 2 · Implant

All models of LOCATOR Overdenture Implant System (74)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 20
Deaths reported: 0
Injuries reported: 20
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840481101533), received between May 15, 2019 and Jul 27, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Loss of Osseointegration11
Failure to Osseointegrate8
Fracture1

Patient problems

Failure of Implant9
No Clinical Signs, Symptoms or Conditions9
Unspecified Infection2

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

InjuryJul 27, 2026Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047724 ↗
InjuryMay 7, 2026Failure to Osseointegrate
NON-INTEGRATION NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117082 ↗
InjuryApr 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176008 ↗
InjuryMay 12, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. REPORTED FOR 2 IMPLANTS AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16923964 ↗
InjuryMay 12, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. REPORTED FOR 2 IMPLANTS AND WERE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16923958 ↗
InjuryMar 2, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16467922 ↗
InjuryMar 2, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16467917 ↗
InjuryJan 24, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16233092 ↗
InjuryJan 20, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16219094 ↗
InjuryOct 18, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION.
Patient problems: Unspecified Infection
MAUDE report 15627110 ↗
InjuryJul 28, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 15121069 ↗
InjuryJul 12, 2022Loss of Osseointegration; Loss of Osseointegration
DOCTOR REPORTED LOSS OF INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 14989165 ↗
InjuryMar 31, 2021Fracture; Fracture
BOTH IMPLANTS HAVE BROKEN IN THE APICAL THIRD.
Patient problems: Failure of Implant
MAUDE report 11599053 ↗
InjuryJan 15, 2021Loss of Osseointegration; Loss of Osseointegration
DR. INDICATED LOSS OF INTEGRATION, TOOTH SITE #27.
Patient problems: Failure of Implant
MAUDE report 11180652 ↗
InjuryJul 27, 2020Failure to Osseointegrate; Failure to Osseointegrate
NON INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 10326744 ↗
InjuryJul 20, 2020Failure to Osseointegrate; Failure to Osseointegrate
NON INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 10297601 ↗
InjuryApr 6, 2020Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED BONE EXPANSION DONE, NO DRILLING. ADDITIONAL CORTICOCANCELLOUS BONE ADDED. IMPLANT REMOVED DUE TO FAILURE TO INTEGRATE WITH INFECTION PRESENT. NO PATIENT HISTORY TO REPORT AND MODERATE BONE TYPE. IMPLANT SITE WAS GRAFTED PREVIOUSLY OR SIMULTANEOUSLY WITH ALLOGRAFT. IMPLANT WAS NOT AND IMMEDIATE PLACEMENT AND WAS DONE IN TWO STAGES. IMPLANT WAS NOT LOAD/RESTORED PRIOR TO FAILURE. XRAY PROVIDED IS FOR SITE 24-25.
Patient problems: Unspecified Infection
MAUDE report 9930471 ↗
InjuryJan 21, 2020Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 9613068 ↗
InjuryJun 5, 2019Failure to Osseointegrate; Failure to Osseointegrate
NO PRIMARY STABILITY. (NON-INTEGRATION).
Patient problems: Failure of Implant
MAUDE report 8672449 ↗
InjuryMay 15, 2019Failure to Osseointegrate; Failure to Osseointegrate
THE IMPLANT FAILED (DID NOT INTEGRATE) IN MOUTH. PATIENT CAME IN FOR A 2 MONTH CHECK-UP, TO CHECK FOR INTEGRATION. ALL IMPLANTS WERE INTEGRATED EXCEPT FOR #22 (07457-S), IT WAS MOBILE, BUT THERE WAS NO PAIN. IMPLANT WAS REMOVED BECAUSE OF NO INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 8614312 ↗

Device details

UDI-DI	`00840481101533`
Brand	LOCATOR Overdenture Implant System
Model	07457
Company	Zest Anchors, LLC
Product code	DZE · IMPLANT, ENDOSSEOUS, ROOT-FORM
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Mar 2, 2026

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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