BioHorizons CTR4212Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.2 x 12mm, RBT · Class 2 · Implant
Quick summary
This is a BioHorizons Tapered Pro conical implant. Most of the 84 reports describe implants failing to bond with the bone. There are 84 reports, no deaths and 84 injuries. No recalls name this device. Reports rose recently, with 56 in the last 12 months compared with 28 in the 12 months before.
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
- 85
- Deaths reported
- 0
- Injuries reported
- 85
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00847236024376), received between Nov 11, 2024 and Sep 29, 2026 — classified as 85 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (65 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 Osseointegrate65
- Use of Device Problem21
Patient problems
- Insufficient Information85
- Encephalocele1
Recent adverse event reports
The 25 most recent of 85 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637101 ↗InjurySep 1, 2026Failure to Osseointegrate
InjuryAug 16, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 7, 2026Failure to Osseointegrate
InjuryJun 24, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 5, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25084600 ↗InjuryMay 5, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryApr 30, 2026Failure to Osseointegrate
InjuryApr 29, 2026Failure to Osseointegrate
InjuryApr 23, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24974302 ↗InjuryApr 8, 2026Failure to Osseointegrate
InjuryApr 6, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24790080 ↗InjuryApr 2, 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.