LOCATOR Overdenture Implant System 07476Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 3.4mmD x 12mmL, 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.
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00840481126116), received between Sep 3, 2021 and Oct 15, 2022 — classified as 8 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (6 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.
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 Osseointegrate6
- Loss of Osseointegration2
Patient problems
- Failure of Implant4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15612393 ↗InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15609718 ↗InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15609679 ↗InjuryOct 14, 2022Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15609649 ↗InjuryDec 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 29, 2021Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 3, 2021Loss of Osseointegration; Loss of Osseointegration
InjurySep 3, 2021Loss of Osseointegration; Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page