LOCATOR Overdenture Implant System 07444Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 12mmL, 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
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00840481129742), received between Apr 4, 2023 and Mar 2, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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 Osseointegrate13
- Loss of Osseointegration2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMar 2, 2026Failure to Osseointegrate
NON-INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24490194 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. LOOSE, ONE REMOVED ON (B)(6) 2025. THESE OTHER TWO WERE REMOVED ON (B)(6) 2025 AND THERE WAS PAIN AND SWELLING FOR THESE TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898315 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. LOOSE, ONE REMOVED ON (B)(6) 2025. THESE OTHER TWO WERE REMOVED ON (B)(6) 2025 AND THERE WAS PAIN AND SWELLING FOR THESE TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898181 ↗InjuryAug 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. LOOSE, ONE REMOVED ON 7/14/2025. THESE OTHER TWO WERE REMOVED ON 8/5/2025 AND THERE WAS PAIN AND SWELLING FOR THESE TWO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22898179 ↗InjuryMay 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS DID NOT INTEGRATE INTO THE BONE, AND THERE WERE NO COMPLICATIONS OTHERWISE; THE IMPLANT JUST CAME OUT OF THE BONE WITH NO EFFORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22081269 ↗InjuryMay 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 5, 2024Loss of Osseointegration; Loss of Osseointegration
IMPLANT FAILED DURING DENTURE PLACEMENT ON (B)(6) 2024. LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680853 ↗InjuryMay 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE CUSTOMER IS REPORTING FELL OUT. ADDITIONAL INFORMATION: PLACED 3 IMPLANTS. 2 FELL OUT, 1 IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355342 ↗InjuryMay 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE CUSTOMER IS REPORTING FELL OUT. ADDITIONAL INFORMATION: PLACED 3 IMPLANTS. 2 FELL OUT, 1 IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355335 ↗InjuryMay 20, 2024Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE CUSTOMER IS REPORTING FELL OUT. ADDITIONAL INFORMATION: PLACED 3 IMPLANTS. 2 FELL OUT, 1 IS LOOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19355333 ↗InjuryFeb 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 14, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17098800 ↗InjuryApr 4, 2023Failure to Osseointegrate; Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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