BioHorizons CTA4212Recalls & reported problems

Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.2 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 420 reports, all listed as injuries, and no deaths. Most reports describe the implant failing to bond with the jawbone, and some describe implants removed soon after placement. Reports rose to 251 in the last year from 165 in the year 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: 423
Deaths reported: 0
Injuries reported: 423
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 423 adverse event reports that list this exact device (DI 00847236024062), received between Aug 21, 2024 and Sep 28, 2026 — classified as 423 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (240 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Failure to Osseointegrate240
Use of Device Problem206
Fracture2
Connection Problem1

Patient problems

Insufficient Information423

Recent adverse event reports

The 25 most recent of 423 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 50914224 ↗
InjurySep 28, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50913896 ↗
InjurySep 21, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50837544 ↗
InjurySep 16, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50788943 ↗
InjurySep 15, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50768588 ↗
InjurySep 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50768544 ↗
InjurySep 15, 2026Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50767920 ↗
InjurySep 10, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50721683 ↗
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710977 ↗
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710589 ↗
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710516 ↗
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710424 ↗
InjurySep 10, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50709387 ↗
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709197 ↗
InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679452 ↗
InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679421 ↗
InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679405 ↗
InjurySep 8, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50669964 ↗
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637087 ↗
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637083 ↗
InjuryAug 28, 2026Failure to Osseointegrate
Implant failed to osseointegrate.
Patient problems: Insufficient Information
MAUDE report 50496051 ↗
InjuryAug 25, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50431985 ↗
InjuryAug 25, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50431969 ↗
InjuryAug 25, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50431956 ↗
InjuryAug 25, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50431951 ↗

Device details

UDI-DI	`00847236024062`
Brand	BioHorizons
Model	CTA4212
Company	Biohorizons Implant Systems, Inc
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	K240187
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 19, 2024

Device type (GMDN): Screw endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

Other Implant, Endosseous, Root-Form devices

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All Implant, Endosseous, Root-Form devices →

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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