BioHorizons TSL4606Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Short Implant, Laser-Lok, 4.6 x 6.0mm, 3.5mm Platform · Class 2 · Implant
Quick summary
This BioHorizons Tapered Short dental implant is placed in the jawbone. Its 644 reports mostly describe the implant failing to bond with the surrounding bone, and most give little other detail. The reports include 644 injuries and no deaths. 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
- 652
- Deaths reported
- 0
- Injuries reported
- 652
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 652 adverse event reports that list this exact device (DI 00847236000653), received between Feb 15, 2024 and Sep 28, 2026 — classified as 652 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (569 reports).
1 other recall cover devices cleared under the same FDA submission (K172576, 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 Osseointegrate569
- Use of Device Problem93
- Fracture2
- Loss of Osseointegration2
- Osseointegration Problem2
- Insufficient Device Problem Information1
- Unexpected Mode Switch1
Patient problems
- Insufficient Information652
- Spinal Cord Injury2
Recent adverse event reports
The 25 most recent of 652 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 21, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 15, 2026Failure to Osseointegrate
InjurySep 14, 2026Failure to Osseointegrate
InjurySep 11, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50741694 ↗InjurySep 11, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50741685 ↗InjurySep 11, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
InjurySep 11, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679407 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50679371 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50643169 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50643168 ↗InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 31, 2026Failure to Osseointegrate
InjuryAug 31, 2026Failure to Osseointegrate; Unexpected Mode Switch
Patient problems: Insufficient Information; Spinal Cord Injury
MAUDE report 50522379 ↗InjuryAug 31, 2026Use of Device Problem
Patient problems: Insufficient Information; Spinal Cord Injury
MAUDE report 50522376 ↗InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K172576, 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
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.