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BioHorizons CTA4209Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.2 x 9mm, Laser-Lok and RBT · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This BioHorizons Tapered Pro Conical implant is a dental implant placed into the jawbone. Most of its 209 reports describe the implant failing to bond with the bone, and some describe implants removed soon after placement. The reports include 209 injuries and no deaths. No recalls name this device. Reports rose to 136 in the last 12 months, from 72 in the 12 months before.

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
213
Deaths reported
0
Injuries reported
213
Recalls naming it
0

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00847236024024), received between Jul 29, 2024 and Sep 21, 2026 — classified as 213 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (122 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: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 1 reportsDec 2024: 5 reportsJan 2025: 2 reportsFeb 2025: 1 reportsMar 2025: 3 reportsApr 2025: 9 reportsMay 2025: 12 reportsJun 2025: 6 reportsJul 2025: 6 reportsAug 2025: 6 reportsSep 2025: 7 reportsOct 2025: 14 reportsNov 2025: 10 reportsDec 2025: 16 reportsJan 2026: 9 reportsFeb 2026: 17 reportsMar 2026: 10 reportsApr 2026: 19 reportsMay 2026: 7 reportsJun 2026: 17 reportsJul 2026: 6 reportsAug 2026: 17 reportsSep 2026: 12 reportsOct 2026: 0 reports20242025202619
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate122
  • Use of Device Problem99
  • Fracture2

Patient problems

  • Insufficient Information213

Recent adverse event reports

The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

  • InjurySep 21, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50837543 ↗
  • InjurySep 21, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50836930 ↗
  • InjurySep 21, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50836876 ↗
  • InjurySep 21, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50836796 ↗
  • InjurySep 21, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50836403 ↗
  • InjurySep 21, 2026Use of Device Problem

    Patient problems: Insufficient Information

    MAUDE report 50834982 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: Insufficient Information

    MAUDE report 50741729 ↗
  • InjurySep 10, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50709498 ↗
  • InjurySep 8, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50669807 ↗
  • InjurySep 8, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50669805 ↗
  • InjurySep 1, 2026Failure to Osseointegrate

    Patient problems: Insufficient Information

    MAUDE report 50540088 ↗
  • InjurySep 1, 2026Failure to Osseointegrate

    Patient problems: Insufficient Information

    MAUDE report 50539891 ↗
  • InjuryAug 31, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50523095 ↗
  • InjuryAug 28, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50495703 ↗
  • InjuryAug 25, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50431895 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430567 ↗
  • InjuryAug 16, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50268462 ↗
  • InjuryAug 16, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50268396 ↗
  • InjuryAug 16, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50268378 ↗
  • InjuryAug 13, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50234883 ↗
  • InjuryAug 7, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50181753 ↗
  • InjuryAug 6, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50165510 ↗
  • InjuryAug 6, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50165470 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50157220 ↗
  • InjuryAug 6, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50152773 ↗

Other Implant, Endosseous, Root-Form devices

All Implant, Endosseous, Root-Form devices →

Sources and updates

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