LOCATOR Overdenture Implant System 07512Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 4.4mmD x 14mmL · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840481131356), received between Aug 19, 2025 and Dec 22, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2 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 Osseointegrate2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. I HAVE A DOCTOR WHO RAN INTO AN ISSUE WHILE PLACING ONE OF OUR IMPLANTS. AS HE WAS INSERTING THE LAST IMPLANT, IT FELT TIGHT, SO HE BACKED OUT AND ATTEMPTED TO REINSERT IT. AS HE WAS TORQUING IT DOWN WITH HIS MOTORIZED HANDPIECE, HE REALIZED IT WAS NO LONGER ENGAGING WITH THE CARRIER. HE THEN TRIED TORQUING MANUALLY AND WITH THE DRIVER, BUT THE IMPLANT STILL WASN'T ENGAGING WITH THE INTERNAL HEX. THE IMPLANT ISN'T FULLY SEATED AT THE CREST, AND HE REMOVED IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872861 ↗InjuryAug 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
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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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