LOCATOR 08633Recalls & reported problems
Zest Anchors, LLC · LOCATOR ABUTMENT BIOMET 3I CERTAIN 4.1 X 4MM · 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 00893202000844), received between Apr 29, 2024 and Apr 29, 2024 — 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.
InjuryApr 29, 2024Fracture; Fracture
IT WAS REPORTED THAT ONE LOCATOR WAS ATTACHED TO THE OSS IMPLANT SITE #12, WHICH HAD BONE LOSS AND WAS FRACTURED. THE OTHER LOCATOR WAS FRACTURED AND IMPLANT HAD TO BE REMOVED TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202902 ↗InjuryApr 29, 2024Fracture; Fracture
IT WAS REPORTED THAT ONE LOCATOR WAS ATTACHED TO THE OSS IMPLANT SITE #12, WHICH HAD BONE LOSS AND WAS FRACTURED. THE OTHER LOCATOR WAS FRACTURED AND IMPLANT HAD TO BE REMOVED TO FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19202900 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.