BioHorizons CTA3812Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 3.8 x 12mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro dental implant has 261 adverse event reports, all of them injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some describe it being removed soon after placement. There are no recalls that 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
- 262
- Deaths reported
- 0
- Injuries reported
- 262
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 262 adverse event reports that list this exact device (DI 00847236023997), received between Aug 22, 2024 and Sep 30, 2026 — classified as 262 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (166 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 Osseointegrate166
- Use of Device Problem107
- Fracture4
Patient problems
- Insufficient Information262
Recent adverse event reports
The 25 most recent of 262 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50788883 ↗InjurySep 3, 2026Failure to Osseointegrate
InjurySep 3, 2026Failure to Osseointegrate
InjuryAug 31, 2026Use of Device Problem; Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50522919 ↗InjuryAug 25, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50431855 ↗InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
Implant failed to osseointegration.
Patient problems: Insufficient Information
MAUDE report 50255547 ↗InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 9, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryJun 24, 2026Use of Device Problem; Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 17, 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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