BioHorizons CTA4609Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.6 x 9mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Tapered Pro implant is a device placed into bone. Many of the 236 reports give little detail beyond the implant failing to fuse with the bone, and some mention problems during use. The reports include 236 injuries and no deaths, and reports rose to 138 in the last 12 months from 97 in the 12 months 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
- 231
- Deaths reported
- 0
- Injuries reported
- 231
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 00847236024178), received between Oct 8, 2024 and Sep 21, 2026 — classified as 231 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (134 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 Osseointegrate134
- Use of Device Problem111
- Fracture1
Patient problems
- Insufficient Information231
- Spinal Cord Injury1
Recent adverse event reports
The 25 most recent of 231 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 16, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50721684 ↗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 50710598 ↗InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 21, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours
Patient problems: Insufficient Information
MAUDE report 50380165 ↗InjuryAug 16, 2026Use of Device Problem; Failure to Osseointegrate
InjuryAug 16, 2026Fracture; Failure to Osseointegrate
InjuryAug 14, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50257335 ↗InjuryAug 14, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50257144 ↗InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 11, 2026Failure to Osseointegrate
InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours
Patient problems: Insufficient Information
MAUDE report 50156755 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50152810 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 15, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 25826118 ↗InjuryJul 13, 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.
How reports and recalls are matched · Editorial policy · Report an error on this page