LOCATOR Overdenture Implant System 07440Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.4mmD 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
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00840481129704), received between Oct 7, 2021 and Dec 22, 2025 — classified as 20 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (17 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 Osseointegrate17
- Loss of Osseointegration3
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- Inadequate Osseointegration2
- Failure of Implant1
- Pain1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
PER DR. RAFIEE, LOST OF INTEGRATION, THE IMPLANT FELL OUT. DR. WOULD LIKE, REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872871 ↗InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215150 ↗InjuryMay 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS FAILED TO OSSEOINTEGRATE INTO THE BONE, RESULTING IN IMPLANT FAILURE AND THE COMPONENTS COMING OUT OF THE BONE. TRIED TO GET THE PLACEMENT DATE, BUT THE ASSISTANT DID NOT KNOW OR HAVE THE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081273 ↗InjuryMay 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS FAILED TO OSSEOINTEGRATE INTO THE BONE, RESULTING IN IMPLANT FAILURE AND THE COMPONENTS COMING OUT OF THE BONE. TRIED TO GET THE PLACEMENT DATE, BUT THE ASSISTANT DID NOT KNOW OR HAVE THE INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081272 ↗InjuryJun 21, 2024Loss of Osseointegration; Loss of Osseointegration
PATIENT HAD SOME PAIN AND THEN WHEN SHE TOOK OUT HER DENTURE, HER IMPLANT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580551 ↗InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON INTEGRATION. IMPLANT DID NOT SIT WELL AND CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175993 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION AND IMPLANT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121933 ↗InjuryApr 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION AND IMPLANT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121930 ↗InjuryDec 20, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. JULY 25TH, IMPLANTS WERE PLACE, LATER PATIENT CAME IN WITH IMPLANTS IN A BAG. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18367084 ↗InjuryDec 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. SURGERY DATE WAS (B)(6) 2022, IMPLANT FAILED AND WAS REMOVED ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16537799 ↗InjuryMar 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS WERE LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240714 ↗InjuryJan 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS WERE LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240713 ↗InjurySep 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
DR. INDICATED NON- INTEGRATION. IMPLANT FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15513780 ↗InjuryApr 7, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryJan 10, 2022Failure to Osseointegrate; Failure to Osseointegrate
DOCTOR REPORTED NON- INTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 13205775 ↗InjuryOct 7, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. CUSTOMER STATES THE IMPLANTS DID NOT OSSEOINTEGRATE AND CAUSED PAIN TO THE PATIENT. ULTIMATELY EXTRACTED THE IMPLANTS VIA A SEPARATE PROCEDURE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 12592151 ↗
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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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