BioHorizons BTA4212Recalls & reported problems
Biohorizons Implant Systems, Inc · 4.2mm x 12mm Tapered Pro Implant, Laser-Lok, RBT · Class 2 · Implant
Quick summary
This BioHorizons Tapered Pro dental implant is a screw placed in the jawbone to hold a replacement tooth. Of its 1,784 reports, all filed as injuries, most describe the implant failing to fuse with the bone, and some say it was removed soon after placement. There are no deaths reported, and 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
- 1,805
- Deaths reported
- 0
- Injuries reported
- 1,805
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,805 adverse event reports that list this exact device (DI 00847236012403), received between Feb 15, 2024 and Sep 29, 2026 — classified as 1,805 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,288 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, K143022, K223697); they may or may not involve this specific model.
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 Osseointegrate1,288
- Use of Device Problem562
- Loss of Osseointegration21
- Fracture10
- Osseointegration Problem3
- Connection Problem1
- Expulsion1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1,805
- Encephalocele1
Recent adverse event reports
The 25 most recent of 1,805 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 50930434 ↗InjurySep 28, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 17, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50800580 ↗InjurySep 17, 2026Failure to Osseointegrate
InjurySep 16, 2026Failure to Osseointegrate
InjurySep 16, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50768877 ↗InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50768545 ↗InjurySep 14, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50750066 ↗InjurySep 11, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50741728 ↗InjurySep 11, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50741723 ↗InjurySep 11, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50741676 ↗InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50711258 ↗InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710702 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, K143022, K223697. One submission often covers many models, so check the product and lot details in each record.
- Z-1111-2025 · Dec 6, 2024 · Open, ClassifiedTemporary Titanium Abutments
- Z-1605-2015 · Apr 16, 2015 · TerminatedTapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
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.