BioHorizons CTR4610Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.6 x 10.5mm, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered conical dental implant is a root-form screw placed in the jawbone. Most of the 54 reports describe the implant failing to fuse with the surrounding bone, with several noting it had to be removed shortly after surgery; no deaths were reported. All 54 reports involved injuries, and they rise sharply in the past 12 months (48 versus 6 in the prior12 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
- 60
- Deaths reported
- 0
- Injuries reported
- 60
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 00847236024413), received between Mar 28, 2025 and Sep 29, 2026 — classified as 60 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (47 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 Osseointegrate47
- Use of Device Problem17
- Fracture1
Patient problems
- Insufficient Information60
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 17, 2026Failure to Osseointegrate
InjurySep 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50788885 ↗InjurySep 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50768120 ↗InjurySep 14, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50751499 ↗InjurySep 10, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 29, 2026Use of Device Problem; Failure to Osseointegrate
InjuryJun 23, 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 25595393 ↗InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 15, 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.