BioHorizons CTA3315Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.3 x 15mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons CTA3315 tapered conical dental implant is a small root-form screw placed in the jaw. The 50 reports mostly describe the implant failing to fuse with the surrounding bone, with surgeons removing it shortly after placement; no deaths and 50 injuries were reported. There are no recalls naming 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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00847236023966), received between Oct 2, 2024 and Sep 28, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (27 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 Osseointegrate27
- Use of Device Problem25
- Connection Problem1
Patient problems
- Insufficient Information50
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50914274 ↗InjurySep 21, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50837175 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679413 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679385 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 1, 2026Failure to Osseointegrate
InjuryJun 15, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 15, 2026Failure to Osseointegrate
InjuryMay 7, 2026Failure to Osseointegrate
InjuryMay 1, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25055298 ↗InjuryApr 28, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryApr 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24820543 ↗InjuryMar 22, 2026Failure to Osseointegrate
InjuryMar 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24616394 ↗InjuryMar 16, 2026Failure to Osseointegrate
InjuryFeb 24, 2026Failure to Osseointegrate
InjuryFeb 17, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 9, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24291383 ↗InjuryJan 26, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24176691 ↗InjuryJan 12, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24039513 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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