LOCATOR Overdenture Implant System 07451Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.4mmD x 12mmL, 2.5mm Cuff · Class 2 · Implant
All models of LOCATOR Overdenture Implant System (74)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Zest Anchors LOCATOR overdenture implant has 272 reports, with no deaths and 272 injuries. Most describe the implant not fusing with the jawbone, a problem called loss of integration. One recall names this device and is open, starting November 2019. It concerns an abutment (the connecting part) that may be out of specification, which could leave a small gap between the implant and abutment during assembly.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 272
- Deaths reported
- 0
- Injuries reported
- 272
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00840481101496), received between May 22, 2019 and May 7, 2026 — classified as 272 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (159 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 22, 2019Class IIOpen, Classified
The abutment provided with the Implant System may be out of specification, which could lead to a small gap occurring between the implant and abutment on assembly in the patient.
Z-2425-2020 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate159
- Loss of Osseointegration101
- Fracture13
Patient problems
- Failure of Implant144
- No Clinical Signs, Symptoms or Conditions90
- No Known Impact Or Consequence To Patient18
- Inadequate Osseointegration10
- Inflammation7
- Pain6
- No Code Available5
- Unspecified Infection5
Recent adverse event reports
The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2026Loss of Osseointegration
LOSS OF INTEGRATION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117079 ↗InjuryMay 7, 2026Loss of Osseointegration
LOSS OF INTEGRATION NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117067 ↗InjuryMay 7, 2026Loss of Osseointegration
LOSS OF INTEGRATION NOTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117065 ↗InjuryApr 3, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778849 ↗InjuryApr 2, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767495 ↗InjuryApr 2, 2026Loss of Osseointegration
LOSS OF INTEGRATION AND NO OTHER INFORMATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24767492 ↗InjuryDec 12, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23458747 ↗InjuryAug 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215151 ↗InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215146 ↗InjuryJun 16, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22215143 ↗InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 17, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21861644 ↗InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21714986 ↗InjuryFeb 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294457 ↗InjuryJan 31, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20516318 ↗InjuryOct 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 16, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 11, 2024Failure 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 · each recall links to the FDA recall notice
- 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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