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BioHorizons CTA3809Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 9mm, Laser-Lok and RBT · Class 2 · Implant

Quick summary

This BioHorizons dental implant is a tooth-root shaped post placed in the jawbone. Most of the 82 reports, all logged as injuries, describe the implant failing to bond with the jawbone. There are no deaths, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
83
Deaths reported
0
Injuries reported
83
Recalls naming it
0

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00847236023973), received between Oct 25, 2024 and Aug 25, 2026 — classified as 83 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (58 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 1 reportsFeb 2025: 4 reportsMar 2025: 1 reportsApr 2025: 3 reportsMay 2025: 2 reportsJun 2025: 7 reportsJul 2025: 3 reportsAug 2025: 4 reportsSep 2025: 3 reportsOct 2025: 5 reportsNov 2025: 6 reportsDec 2025: 3 reportsJan 2026: 3 reportsFeb 2026: 7 reportsMar 2026: 0 reportsApr 2026: 8 reportsMay 2026: 4 reportsJun 2026: 6 reportsJul 2026: 3 reportsAug 2026: 5 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520268
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate58
  • Use of Device Problem31
  • Misconnection1

Patient problems

  • Insufficient Information83

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50431722 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430319 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430311 ↗
  • InjuryAug 21, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50375307 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50142682 ↗
  • InjuryJul 9, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25773884 ↗
  • InjuryJul 6, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25717756 ↗
  • InjuryJul 2, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 25697182 ↗
  • InjuryJun 17, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25532051 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25526663 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25526650 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25457944 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25457710 ↗
  • InjuryJun 2, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25367886 ↗
  • InjuryMay 15, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25186347 ↗
  • InjuryMay 15, 2026Use of Device Problem; Failure to Osseointegrate

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS

    Patient problems: Insufficient Information

    MAUDE report 25184619 ↗
  • InjuryMay 14, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25178035 ↗
  • InjuryMay 12, 2026Use of Device Problem

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Patient problems: Insufficient Information

    MAUDE report 25155667 ↗
  • InjuryApr 17, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE

    Patient problems: Insufficient Information

    MAUDE report 24910149 ↗
  • InjuryApr 15, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24891703 ↗
  • InjuryApr 8, 2026Use of Device Problem

    IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.

    Patient problems: Insufficient Information

    MAUDE report 24820516 ↗
  • InjuryApr 8, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24820456 ↗
  • InjuryApr 7, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24798814 ↗
  • InjuryApr 6, 2026Misconnection; Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24789916 ↗
  • InjuryApr 6, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 24789752 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.