LOCATOR Overdenture Implant System 07504-02Recalls & reported problems
Zest Anchors, LLC · LOCATOR Overdenture Implant, 3.5mmD x 14mmL, 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
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840481130915), received between Mar 3, 2023 and Jan 27, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3 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 Osseointegrate3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 27, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO INTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21245884 ↗InjuryMar 23, 2023Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 3, 2023Failure to Osseointegrate; Failure to Osseointegrate
NON-INTEGRATION. IMPLANT CAUSED PATIENT INFECTION AND HAD TO BE REMOVED.
Patient problems: Unspecified Infection
MAUDE report 16482123 ↗
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- 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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