LOCATOR Overdenture Implant System 07510-02Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 4.4mmD x 10mmL, 2.5mm 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
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00840481131219), received between May 9, 2022 and Sep 16, 2025 — classified as 10 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 Osseointegration3
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Implant Pain2
- Failure of Implant1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23069542 ↗InjuryFeb 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 7, 2024Fracture; Fracture
THREAD FRACTURED. IMPLANT PLACED DURING PLACEMENT HEX ON TOP OF IMPLANT STRIPED AND COULD NOT BE ADJUSTED OR REMOVED AND HAD TO BE CUT OUT OF THE BONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20635878 ↗InjurySep 18, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION. IMPLANT FAILED DUE TO PERIODONTITIS OR SMOKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17765498 ↗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 17691360 ↗InjuryMay 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 20, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. FAILED PRIMARY STABILITY. REMOVED AND PLACED LARGER IMPLANT.
Patient problems: Failure of Implant
MAUDE report 14337773 ↗
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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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