LOCATOR Overdenture Implant System 07465Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 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 Zest LOCATOR overdenture implant is a screw placed in the jawbone to support a denture. Its 239 reports mostly describe the implant failing to fuse with the jawbone. The reports include 239 injuries and no deaths, and reports fell from 21 in the prior 12 months to 5 in the last 12 months. One recall, open since November 2019, covers abutments that may leave a small gap between the implant and abutment.
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
- 239
- Deaths reported
- 0
- Injuries reported
- 239
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00840481101571), received between May 15, 2019 and Jul 27, 2026 — classified as 239 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (136 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
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 Osseointegrate136
- Loss of Osseointegration98
- Fracture5
Patient problems
- Failure of Implant119
- No Clinical Signs, Symptoms or Conditions93
- Inadequate Osseointegration11
- No Known Impact Or Consequence To Patient8
- Unspecified Infection6
- Osteolysis3
- Pain3
- Discomfort2
Recent adverse event reports
The 25 most recent of 239 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Loss of Osseointegration
Loss of osstellintegration and it was very loose the doctor had to remove it.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50047727 ↗InjuryMay 7, 2026Failure to Osseointegrate
NON-INTEGRATION NOTED. THE IMPLANTS WERE INSERTED ACCORDING TO THE LODIS INSTRUCTIONS FOR USE AND SCREWED IN WITH A DEHMOMENT OF 30NCM. THUS GOOD OSSEOSTABILITY. A MONTH LATER, THE PATIENT CAME WITH THE SPONTANEOUSLY EXPLANTED IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117351 ↗InjuryMay 7, 2026Failure to Osseointegrate
NON-INTEGRATION NOTED. THE IMPLANTS WERE INSERTED ACCORDING TO THE LODIS INSTRUCTIONS FOR USE AND SCREWED IN WITH A DEHMOMENT OF 30NCM. THUS GOOD OSSEOSTABILITY. A MONTH LATER, THE PATIENT CAME WITH THE SPONTANEOUSLY EXPLANTED IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117072 ↗InjuryMay 7, 2026Failure to Osseointegrate
NON-INTEGRATION NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117066 ↗InjuryDec 22, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872858 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928149 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928127 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928114 ↗InjuryAug 29, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928088 ↗InjuryAug 6, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22732865 ↗InjuryJul 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE 14 FAILED TO INTEGRATE AND THEREFORE HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22548901 ↗InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045316 ↗InjuryMay 19, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045180 ↗InjuryMay 14, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22020872 ↗InjuryApr 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21821137 ↗InjuryApr 10, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21821135 ↗InjuryApr 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. NO INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21459120 ↗InjuryFeb 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IT WAS REPORTED THAT THE IMPLANTS FAILED TO INTEGRATE AND WERE REMOVED. BONE TYPE WAS 33, 43 AND UNKNOWN. NO IMPACT ON PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119803 ↗InjuryJan 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IT WAS REPORTED THAT THE IMPLANTS FAILED TO INTEGRATE AND WERE REMOVED. BONE TYPE WAS 33, 43 AND UNKNOWN. NO IMPACT ON PATIENT'S HEALTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21119802 ↗InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page