BioHorizons TIM8009Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered IM Implant 8mm X 9mm, Laser-Lok, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered dental implant has 144 FDA adverse event reports, with no deaths and 144 injuries. Most describe the implant failing to fuse with the jawbone, and some mention problems during use. None of the reports include patient details. 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
- 144
- Deaths reported
- 0
- Injuries reported
- 144
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 00847236012496), received between Feb 16, 2024 and Sep 10, 2026 — classified as 144 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (93 reports).
1 other recall cover devices cleared under the same FDA submission (K182070, 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 Osseointegrate93
- Use of Device Problem55
- Loss of Osseointegration1
Patient problems
- Insufficient Information144
Recent adverse event reports
The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Failure to Osseointegrate
InjurySep 8, 2026Failure to Osseointegrate
InjurySep 6, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50637073 ↗InjuryAug 25, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryMay 29, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25338140 ↗InjuryMay 21, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 25250081 ↗InjuryMay 20, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25236620 ↗InjuryMay 15, 2026Failure to Osseointegrate
InjuryApr 28, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25014710 ↗InjuryApr 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 24889637 ↗InjuryApr 9, 2026Failure to Osseointegrate
InjuryApr 7, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24803841 ↗InjuryApr 3, 2026Failure to Osseointegrate
InjuryApr 1, 2026Failure to Osseointegrate
InjuryApr 1, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24753611 ↗InjuryMar 22, 2026Failure to Osseointegrate
InjuryMar 16, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24607055 ↗InjuryMar 9, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24545426 ↗InjuryFeb 26, 2026Failure to Osseointegrate
InjuryFeb 26, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24456542 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K182070, 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.