BioHorizons CTA3309Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.3 x 9mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro Conical implant is a screw-shaped dental implant placed in the jawbone. Most of the 65 reports describe the implant failing to fuse with the bone, so it was removed, and a few mention the implant breaking. There are 65 injuries and no deaths. No recalls name this device. Such reports rose from 19 in the earlier 12 months to 46 in the most recent 12.
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
- 65
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00847236023904), received between Jan 30, 2025 and Sep 30, 2026 — classified as 65 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (41 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate41
- Use of Device Problem25
- Fracture2
Patient problems
- Insufficient Information65
Recent adverse event reports
The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 21, 2026Failure to Osseointegrate
InjuryAug 17, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50280719 ↗InjuryAug 10, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryJun 16, 2026Failure to Osseointegrate
InjuryJun 11, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 20, 2026Failure to Osseointegrate
InjuryApr 16, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24901565 ↗InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 9, 2026Failure to Osseointegrate
InjuryApr 9, 2026Failure to Osseointegrate
InjuryApr 7, 2026Failure to Osseointegrate
InjuryMar 22, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS..
Patient problems: Insufficient Information
MAUDE report 24658730 ↗InjuryMar 19, 2026Failure to Osseointegrate
InjuryMar 18, 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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