LOCATOR Overdenture Implant System 07511-03Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 4.4mmD x 12mmL, 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00840481131271), received between Sep 6, 2023 and Jul 10, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
- Loss of Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 3, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 19, 2024Failure to Osseointegrate; Failure to Osseointegrate
THE IMPLANTS JUST POPPED OUT, THIS IS DUE TO THE PT. BEING A SMOKER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567240 ↗InjuryMar 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DID NOT INTEGRATE. NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17847486 ↗InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DID NOT INTEGRATE. NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17847259 ↗InjurySep 29, 2023Failure to Osseointegrate; Failure to Osseointegrate
IMPLANT DID NOT INTEGRATE. NON-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17847217 ↗InjurySep 8, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IMPLANT FAILED DUE TO PERIODONTITIS OR SMOKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17715644 ↗InjurySep 6, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF NTEGRATION. IMPLANT FAILED DUE TO PERIODONTITIS OR SMOKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17691273 ↗
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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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