LOCATOR 08631Recalls & reported problems
Zest Anchors, LLC · LOCATOR ABUTMENT BIOMET 3I CERTAIN 4.1 X 2MM · Class 2 · Implant
All models of LOCATOR (33)
Data updated Oct 16, 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 00893202000820), received between Mar 30, 2022 and Aug 1, 2025 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Failure to Osseointegrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 1, 2025Fracture; Fracture
(B)(6) 2024 CONSULT FX LOCATOR ABUTMENT. (B)(6) 2025 FX LOCATOR SCREW COULD NOT BE REMOVED. SECOND OPINION ALSO COULD NOT REMOVE. SO, PLAN IS TO REMOVE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22688855 ↗InjuryJan 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT LOCATOR ABUTMENT FRACTURED AT THE THREADS OF THE ABUTMENT. DOCTOR TRIED TO REMOVE THE FRACTURED PORTION BUT IT WAS NOT POSSIBLE. IMPLANT WAS REMOVED AND A NEW IMPLANT WAS PLACED. IMPLANT REFERENCE: (B)(4). IMPLANT LOT: 2022040382.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16211118 ↗InjuryMar 30, 2022Fracture; Fracture
DOCTOR REPORTED LOCATOR FRACTURE INSIDE OF THE IMPLANT AT TOOTH SITE 15. IMPLANT HAD TO BE REMOVED DUE TO FRACTURE.
Patient problems: Insufficient Information
MAUDE report 13953100 ↗
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- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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