LOCATOR Overdenture Implant System 07475Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 3.4mmD 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
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840481126109), received between Mar 16, 2020 and Aug 29, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 Osseointegrate3
- Loss of Osseointegration1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 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 22928143 ↗InjuryNov 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 16, 2020Failure to Osseointegrate; Failure to Osseointegrate
DR PLACED THESE IMPLANTS AND WHEN PLACING THE ABUTMENTS ON THE IMPLANTS CAME OUT.
Patient problems: Failure of Implant
MAUDE report 9835445 ↗InjuryMar 16, 2020Failure to Osseointegrate; Failure to Osseointegrate
DR PLACED THESE IMPLANTS AND WHEN PLACING THE ABUTMENTS ON THE IMPLANTS CAME OUT.
Patient problems: Failure of Implant
MAUDE report 9835432 ↗
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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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