BioHorizons CTR5209Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 5.2 x 9mm, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered root-form dental implant is used to anchor a replacement tooth in the jawbone. The 39 reports mostly describe the implant failing to fuse with the surrounding bone, so it has to be taken back out, in some cases within a day and a half of surgery. There are 39 injuries and no deaths, and no recalls name this device. Reports have risen sharply, from 8 in the earlier 12 months to 31 in the most recent.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00847236024451), received between Feb 28, 2025 and Sep 28, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (25 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 Osseointegrate25
- Use of Device Problem15
Patient problems
- Insufficient Information38
Recent adverse event reports
The 25 most recent of 38 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 50914193 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710978 ↗InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 8, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 21, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryMay 26, 2026Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25276144 ↗InjuryMay 21, 2026Failure to Osseointegrate
InjuryApr 23, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 20, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24926041 ↗InjuryApr 10, 2026Failure to Osseointegrate
InjuryMar 17, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24616543 ↗InjuryFeb 25, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryFeb 6, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24277157 ↗InjuryFeb 5, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24272864 ↗InjuryDec 22, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23863666 ↗InjuryDec 21, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
InjuryDec 15, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23808885 ↗
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.