LOCATOR Overdenture Implant System 07381Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.4mmD x 10mmL · 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
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00840481129612), received between Mar 7, 2022 and Aug 25, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (10 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 Osseointegrate10
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Failure of Implant2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Failure to Osseointegrate
NON- INTEGRATION.PT CAME INTO OFFICE STATED IMPLANT SHOWING THROUGH THE GUM, X-RAY SHOWED NOT INTEGRATED. DR. REMOVED THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440571 ↗InjuryMay 15, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22029225 ↗InjuryJul 17, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IMPLANTATION ACCORDING TO THE PROTOCOL, PROCEED WITHOUT COMPLICATIONS, REMOVAL OF THE IMPLANT ALONG WITH THE PROSTHESIS. PATIENT; FEMALE AGE 62.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153462 ↗InjuryMar 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 1, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 9, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. LOST INTEGRATION AND HAD INFECTION, TENDERNESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16336832 ↗InjuryOct 21, 2022Loss of Osseointegration; Loss of Osseointegration
PLACED # 5 ZEST LODI IMPLANT ON (B)(6) 2022, PLACED ABUTMENT (B)(6) 2022, LOOSE IMPLANT (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15650437 ↗InjuryMar 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13685339 ↗InjuryMar 7, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IMPLANT FAILED TO INTEGRATE.
Patient problems: Failure of Implant
MAUDE report 13685282 ↗
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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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