BioHorizons CTR4612Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.6 x 12mm, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered conical dental implant is a small screw used to anchor a tooth replacement in the jaw. Most of the 43 reports describe the implant failing to fuse with the surrounding bone, with some removed shortly after surgery; there were 43 injuries and no deaths, and reports rose from 12 in the prior 12 months to 31 in 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
- 44
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00847236024420), received between Feb 5, 2025 and Sep 21, 2026 — classified as 44 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (31 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
- Failure to Osseointegrate31
- Use of Device Problem18
- Fracture1
Patient problems
- Insufficient Information44
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 3, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50581644 ↗InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 23, 2026Fracture; Use of Device Problem
IMPLANT REMOVED DUE TO DRIVER BREAKING DURING PLACEMENT (CRIDR/ LOT UNK).
Patient problems: Insufficient Information
MAUDE report 25595699 ↗InjuryJun 19, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 8, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 25426613 ↗InjuryMay 22, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25254955 ↗InjuryMay 21, 2026Failure to Osseointegrate
InjuryMay 21, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryApr 7, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryMar 22, 2026Failure to Osseointegrate
InjuryMar 20, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24649561 ↗InjuryMar 2, 2026Failure to Osseointegrate
InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 14, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24340646 ↗InjuryFeb 13, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24333060 ↗InjuryFeb 9, 2026Failure to Osseointegrate
InjuryFeb 9, 2026Failure to Osseointegrate
InjuryJan 23, 2026Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.