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BioHorizons CTR4210Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.2 x 10.5mm, RBT · Class 2 · Implant

Quick summary

This BioHorizons Tapered Pro dental implant, a screw placed in the jawbone to support a replacement tooth, has 116 adverse event reports on file. Most describe the implant failing to fuse with the jawbone, and the reports give little other detail. The reports include no deaths and 116 injuries, and the number of reports rose from 22 to 94 over the last 12 months. 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
120
Deaths reported
0
Injuries reported
120
Recalls naming it
0

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00847236024369), received between Dec 3, 2024 and Sep 29, 2026 — classified as 120 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (96 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: 0 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 4 reportsMar 2025: 2 reportsApr 2025: 3 reportsMay 2025: 1 reportsJun 2025: 0 reportsJul 2025: 3 reportsAug 2025: 4 reportsSep 2025: 1 reportsOct 2025: 3 reportsNov 2025: 6 reportsDec 2025: 10 reportsJan 2026: 4 reportsFeb 2026: 4 reportsMar 2026: 7 reportsApr 2026: 13 reportsMay 2026: 12 reportsJun 2026: 14 reportsJul 2026: 5 reportsAug 2026: 18 reportsSep 2026: 5 reportsOct 2026: 0 reports20242025202618
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate96
  • Use of Device Problem31
  • Fracture1

Patient problems

  • Insufficient Information120

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours

    Patient problems: Insufficient Information

    MAUDE report 50930493 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50914089 ↗
  • InjurySep 17, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50800150 ↗
  • InjurySep 10, 2026Use of Device Problem

    Patient problems: Insufficient Information

    MAUDE report 50721806 ↗
  • InjurySep 1, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50540106 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430577 ↗
  • InjuryAug 25, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50430558 ↗
  • InjuryAug 17, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50280714 ↗
  • InjuryAug 17, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50280702 ↗
  • InjuryAug 17, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50280697 ↗
  • InjuryAug 16, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50268457 ↗
  • InjuryAug 16, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50268439 ↗
  • InjuryAug 14, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50256881 ↗
  • InjuryAug 14, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50256584 ↗
  • InjuryAug 14, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50256571 ↗
  • InjuryAug 11, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50214740 ↗
  • InjuryAug 11, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50211182 ↗
  • InjuryAug 6, 2026Use of Device Problem

    Implant removed due to surgical consideration within 36 hours.

    Patient problems: Insufficient Information

    MAUDE report 50165552 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50165488 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50165475 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50141760 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50141535 ↗
  • InjuryAug 3, 2026Failure to Osseointegrate

    Implant failed to osseointegrate.

    Patient problems: Insufficient Information

    MAUDE report 50118739 ↗
  • InjuryJul 22, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25909384 ↗
  • InjuryJul 12, 2026Failure to Osseointegrate

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Patient problems: Insufficient Information

    MAUDE report 25791487 ↗

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.