LOCATOR Overdenture Implant System 07501-03Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 3.5mmD x 8mmL, 3mm 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00840481130779), received between Dec 7, 2021 and Apr 24, 2024 — classified as 7 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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
Most reported problems
Device problems
- Failure to Osseointegrate6
- Loss of Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION AND IMPLANT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19176002 ↗InjuryMar 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18895475 ↗InjuryJul 7, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17283053 ↗InjuryDec 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16077262 ↗InjuryJul 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. NO PRIMARY STABILITY. POOR BONE QUALITY.
Patient problems: Failure of Implant
MAUDE report 12956413 ↗
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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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