BioHorizons CTA3312Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.3 x 12mm, Laser-Lok and RBT · Class 2 · Implant
Quick summary
This BioHorizons Tapered Pro Conical implant is a screw-shaped implant placed into bone. Its 149 reports mostly describe the implant failing to fuse with the bone, and some say it was removed soon after placement. The reports include 149 injuries and no deaths. Reports rose to 100 in the last 12 months from 48 in the 12 months before. 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
- 151
- Deaths reported
- 0
- Injuries reported
- 151
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00847236023959), received between Sep 11, 2024 and Sep 29, 2026 — classified as 151 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (104 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 Osseointegrate104
- Use of Device Problem53
- Fracture1
Patient problems
- Insufficient Information151
Recent adverse event reports
The 25 most recent of 151 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 50933868 ↗InjurySep 29, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50933829 ↗InjurySep 28, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50914151 ↗InjurySep 28, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50836092 ↗InjurySep 15, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721778 ↗InjurySep 10, 2026Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50711051 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679370 ↗InjurySep 8, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours
Patient problems: Insufficient Information
MAUDE report 50669802 ↗InjuryAug 24, 2026Failure to Osseointegrate
InjuryAug 17, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50280703 ↗InjuryAug 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50268394 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156940 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156584 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156532 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156518 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryJul 21, 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.