LOCATOR Overdenture Implant System 07456Recalls & reported problems

Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 4mm Cuff · Class 2 · Implant

All models of LOCATOR Overdenture Implant System (74)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This LOCATOR overdenture implant is a dental implant placed into bone to hold a denture. Most of the 126 reports describe the implant failing to bond with the bone or losing that bond. The reports include no deaths and 126 injuries. Reports fell to 0 in the last 12 months from 12 in the previous 12. There is 1 open recall, from November 2019, over a connecting piece that may be out of specification and leave a small gap with the implant.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 126
Deaths reported: 0
Injuries reported: 126
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00840481101526), received between May 22, 2019 and Aug 29, 2025 — classified as 126 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (65 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Nov 22, 2019Class IIOpen, Classified
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Z-2425-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Failure to Osseointegrate65
Loss of Osseointegration57
Fracture4

Patient problems

Failure of Implant71
No Clinical Signs, Symptoms or Conditions35
Unspecified Infection8
No Known Impact Or Consequence To Patient7
Inadequate Osseointegration4
Inflammation3
Implant Pain2
Pain2

Recent adverse event reports

The 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928118 ↗
InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22732862 ↗
InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. NO OTHER INFORMATION WAS PROVIDED BY THE ACCOUNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215590 ↗
InjuryMay 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029230 ↗
InjuryMay 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029226 ↗
InjuryMay 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22028430 ↗
InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21862223 ↗
InjuryMar 7, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE PATIENT INTRODUCED HIMSELF WITH AN IMPLANT LOSS 13. THE PATIENT STATES THAT HE LOST THE IMPLANT WHILE REMOVING HIS PROTHESIS AT HOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21551805 ↗
InjuryJan 31, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21283906 ↗
InjuryJan 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21266041 ↗
InjuryJan 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21266039 ↗
InjuryJan 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS IF INTEGRATION. EXPLANTATION ON (B)(6) 2024. IMPLANT LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21245959 ↗
InjuryAug 5, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19909213 ↗
InjuryJul 5, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680866 ↗
InjuryMay 3, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243242 ↗
InjuryApr 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175997 ↗
InjuryApr 24, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175989 ↗
InjuryApr 1, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19012017 ↗
InjuryMar 1, 2024Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18822218 ↗
InjuryFeb 29, 2024Loss of Osseointegration; Loss of Osseointegration
DR. REPORTED LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18809520 ↗
InjuryFeb 29, 2024Loss of Osseointegration; Loss of Osseointegration
DR. REPORTED LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18809519 ↗
InjuryFeb 2, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18635770 ↗
InjuryAug 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17578415 ↗
InjuryAug 9, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. PATIENT HAS AN INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17494569 ↗
InjuryAug 2, 2023Fracture; Fracture
THERE ARE NO IMPLANT FRAGMENTS IN THE PATIENT'S JAW. FRAGMENT WAS DISPOSED OF IN PRACTICE. IMPLANT FRACTURE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17444263 ↗

Device details

UDI-DI	`00840481101526`
Brand	LOCATOR Overdenture Implant System
Model	07456
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 · each recall links to the FDA recall notice
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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