BioHorizons TLR4607Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant RBT, Laser-Lok 4.6 x 7.5mm, 4.5 Platform · Class 2 · Implant
Quick summary
This BioHorizons Tapered Internal implant is a tapered implant placed into bone. All 165 of its adverse event reports are injuries, with no deaths, and most describe the implant failing to fuse with the surrounding bone. The reports give insufficient patient information. 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
- 169
- Deaths reported
- 0
- Injuries reported
- 169
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 00847236009892), received between Feb 17, 2024 and Sep 21, 2026 — classified as 169 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (156 reports).
2 other recalls cover devices cleared under the same FDA submission (K071638, 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 Osseointegrate156
- Use of Device Problem16
- Loss of Osseointegration2
- Fracture1
- Osseointegration Problem1
Patient problems
- Insufficient Information169
Recent adverse event reports
The 25 most recent of 169 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834974 ↗InjurySep 21, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50834947 ↗InjurySep 14, 2026Failure to Osseointegrate
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637020 ↗InjuryAug 12, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 22, 2026Failure to Osseointegrate
InjuryJul 16, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 26, 2026Failure to Osseointegrate
InjuryJun 25, 2026Failure to Osseointegrate
InjuryJun 10, 2026Failure to Osseointegrate
InjuryMay 27, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 12, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryApr 22, 2026Failure to Osseointegrate
InjuryApr 11, 2026Failure to Osseointegrate
InjuryApr 6, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryMar 17, 2026Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K071638, 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.