LOCATOR 01554Recalls & reported problems
Zest Anchors, LLC · LOCATOR Abutment for 4.0 GS Standard, Osstem x 4.0mm · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840481103889), received between Aug 19, 2025 and Aug 19, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Fracture; Fracture
FRACTURED LOCATORS. DR. (B)(6) EMAILED A REPRESENTATIVE REGARDING ISSUES WITH A FIXED DENTURE. DURING THIS TIME, TWO LOCATOR® ABUTMENTS FRACTURED. THE CASE HAD A SLIGHTLY LONG CANTILEVER, WHICH COULD PLACE LATERAL FORCES ON THE DENTURE AND POTENTIALLY CAUSE FRACTURES IN CERTAIN PARTS. IT IS UNCLEAR IF THE ABUTMENTS WILL BE RETURNED, BUT THE DENTIST IS REQUESTING CREDIT, AS HE IS NOT YET SURE WHICH IMPLANTS WILL BE PLACED IN THE PATIENT'S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844198 ↗InjuryAug 19, 2025Fracture; Fracture
FRACTURED LOCATORS. DR. (B)(6) EMAILED A REPRESENTATIVE REGARDING ISSUES WITH A FIXED DENTURE. DURING THIS TIME, TWO LOCATOR® ABUTMENTS FRACTURED. THE CASE HAD A SLIGHTLY LONG CANTILEVER, WHICH COULD PLACE LATERAL FORCES ON THE DENTURE AND POTENTIALLY CAUSE FRACTURES IN CERTAIN PARTS. IT IS UNCLEAR IF THE ABUTMENTS WILL BE RETURNED, BUT THE DENTIST IS REQUESTING CREDIT, AS HE IS NOT YET SURE WHICH IMPLANTS WILL BE PLACED IN THE PATIENT'S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22844134 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.