LOCATOR Overdenture Implant System 07467Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 14mmL, 4mm 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 LOCATOR overdenture implant is a small root-form dental implant used to anchor replacement overdentures. The 34 adverse event reports mostly describe the implant failing to bond with the jawbone or losing that bond after it was placed, with a few reports of infection; all 34 involve injuries and no deaths. One recall, started in November 2019 and still open, says the matching abutment may have been made slightly off size, which could leave a small gap between implant and abutment once assembled in the mouth.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00840481101595), received between May 22, 2019 and Nov 3, 2025 — classified as 34 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 Osseointegrate22
- Loss of Osseointegration12
Patient problems
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions11
- No Known Impact Or Consequence To Patient3
- Inadequate Osseointegration2
- Rheumatoid Arthritis1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 18, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 9, 2023Loss of Osseointegration; Loss of Osseointegration
InjuryDec 15, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION REPORTED. IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 LOST INTEGRATION AND WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992071 ↗InjuryNov 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15798889 ↗InjuryNov 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15798787 ↗InjuryOct 29, 2022Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEO-INTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15695314 ↗InjuryAug 25, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. PRIMARY STABILITY COULD NOT BE ACHIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15298840 ↗InjuryAug 8, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration
ABUTMENTS CAME LOOSE FROM IMPLANTS PATIENT LOST ABUTMENTS. DOCTOR (B)(6) WAS CONTACTED BY PHONE, AND HE INDICATED THAT THE IMPLANTS WERE NOT AFFECTED BY THE EVENT AND THE PATIENT LOST 3 OUT OF THE 4 ABUTMENTS; THE ONE AVAILABLE WILL BE RETURNED TO ZEST FOR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 15158708 ↗InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration
ABUTMENTS CAME LOOSE FROM IMPLANTS PATIENT LOST ABUTMENTS. DOCTOR (B)(6) WAS CONTACTED BY PHONE, AND HE INDICATED THAT THE IMPLANTS WERE NOT AFFECTED BY THE EVENT AND THE PATIENT LOST 3 OUT OF THE 4 ABUTMENTS; THE ONE AVAILABLE WILL BE RETURNED TO ZEST FOR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 15158704 ↗InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration
ABUTMENTS CAME LOOSE FROM IMPLANTS PATIENT LOST ABUTMENTS. DOCTOR (B)(6) WAS CONTACTED BY PHONE, AND HE INDICATED THAT THE IMPLANTS WERE NOT AFFECTED BY THE EVENT AND THE PATIENT LOST 3 OUT OF THE 4 ABUTMENTS; THE ONE AVAILABLE WILL BE RETURNED TO ZEST FOR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 15158703 ↗InjuryAug 3, 2022Loss of Osseointegration; Loss of Osseointegration
ABUTMENTS CAME LOOSE FROM IMPLANTS PATIENT LOST ABUTMENTS. DOCTOR (B)(6) WAS CONTACTED BY PHONE, AND HE INDICATED THAT THE IMPLANTS WERE NOT AFFECTED BY THE EVENT AND THE PATIENT LOST 3 OUT OF THE 4 ABUTMENTS; THE ONE AVAILABLE WILL BE RETURNED TO ZEST FOR EVALUATION.
Patient problems: Failure of Implant
MAUDE report 15158700 ↗InjuryAug 2, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 20, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS DID NOT OSSEO-INTEGRATE IN THE BONE AND THERE WAS A LOT OF BONE LOSS THAT OCCURRED DURING HEALING TIME.
Patient problems: Failure of Implant
MAUDE report 11562919 ↗InjuryMar 24, 2021Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANTS DID NOT OSSEO-INTEGRATE IN THE BONE AND THERE WAS A LOT OF BONE LOSS THAT OCCURRED DURING HEALING TIME.
Patient problems: Failure of Implant
MAUDE report 11562914 ↗InjuryMar 17, 2021Failure to Osseointegrate; Failure to Osseointegrate
DR. INDICATED NON INTEGRATION, TOOTH SITES # 26-23.
Patient problems: Inadequate Osseointegration
MAUDE report 11504344 ↗InjuryMar 16, 2021Failure to Osseointegrate; Failure to Osseointegrate
DR. INDICATED NON INTEGRATION, TOOTH SITES # 26-23.
Patient problems: Failure of Implant
MAUDE report 11498366 ↗InjuryFeb 8, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 11, 2020Failure to Osseointegrate; Failure to Osseointegrate
NON INTEGRATION. DOCTOR REPORTED NON INTEGRATION.
Patient problems: Failure of Implant
MAUDE report 10824960 ↗InjurySep 23, 2020Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #22 FAILED TO INTEGRATE AND WAS REMOVED.
Patient problems: Inadequate Osseointegration
MAUDE report 10577129 ↗
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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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