LOCATOR Overdenture Implant System 07443Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 2.9mmD x 10mmL, 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
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00840481129735), received between May 12, 2022 and Dec 22, 2025 — classified as 14 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 Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Failure of Implant2
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. AFTER PLACING THE IMPLANT, THEY ATTEMPTED TO PLACE THE ABUTMENT BUT IT WOULD NOT ENGAGE, CUSTOMER REALIZED THE IMPLANT WAS MISSING THE THREADING. DR. DID HAVE TO REMOVE STITCHING TO REMOVE THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872859 ↗InjuryMay 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 4, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 22, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2024Failure to Osseointegrate; Failure to Osseointegrate
LOSS OF INTEGRATION AND IMPLANT CAME OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19175988 ↗InjuryApr 16, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF INTEGRATION AND IMPLANT CAME OUT. PT HAD A LITTLE SORENESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121934 ↗InjuryFeb 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 13, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON- INTEGRATION. IMPLANT CAUSED PATIENT AN INFECTION HAD TO BE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17740783 ↗InjuryMar 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. BONE WAS TOO SOFT AND IMPLANT FAILED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16555032 ↗InjuryMar 16, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IMPLANT FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16555022 ↗InjuryJan 25, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. DOCTOR. PLACED 4 IMPLANTS AND THE IMPLANT PROCESS WENT WELL. ALL TORQUED TO 20 NC. WHEN PATIENT CAME BACK A WEEK LATER, THE IMPLANT WAS SO LOOSE IT, DR. PULLED IT OUT WITH HIS FINGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16240712 ↗InjuryNov 16, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15809164 ↗InjuryJun 30, 2022Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. THE IMPLANT DID NOT INTEGRATE INTO BONE.
Patient problems: Failure of Implant
MAUDE report 14876651 ↗InjuryMay 12, 2022Failure to Osseointegrate; Failure to Osseointegrate
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- 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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