LOCATOR Overdenture Implant System 07502-03Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 3.5mmD x 10mmL, 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 00840481130823), received between Mar 23, 2022 and Oct 15, 2025 — 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
- Swelling/ Edema1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23294710 ↗InjuryJul 30, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IMPLANT DID NOT INTEGRATE INTO THE BONE AND CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19863273 ↗InjuryJan 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. PATIENT CAME IN WITH THE IMPLANT IN HER HAND. IMPLANT DIDN'T INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17098802 ↗InjuryJul 28, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 23, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. SWELLING/INFECTION. DID NOT OSSEO-INTEGRATE. AFTER IMPLANT REMOVAL, SWELLING AND INFECTION HAVE GONE DOWN.
Patient problems: Failure of Implant; Swelling/ Edema; Unspecified Infection
MAUDE report 13861165 ↗
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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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