BioHorizons TIM8010Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered IM Implant 8mm X 10.5mm, Laser-Lok, RBT · Class 2 · Implant
Quick summary
This BioHorizons tapered dental implant has 168 reports, with no deaths and 168 injuries. Most reports describe the implant failing to fuse with the jawbone, and many have little detail beyond that. 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
- 168
- Deaths reported
- 0
- Injuries reported
- 168
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 00847236012502), received between Feb 24, 2024 and Sep 1, 2026 — classified as 168 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (110 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 Osseointegrate110
- Use of Device Problem64
- Loss of Osseointegration2
- Fracture1
Patient problems
- Insufficient Information168
Recent adverse event reports
The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.
InjurySep 1, 2026Failure to Osseointegrate
InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50156686 ↗InjuryJul 21, 2026Failure to Osseointegrate
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJun 29, 2026Failure to Osseointegrate
InjuryJun 23, 2026Use of Device Problem; Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
InjuryJun 2, 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 25285768 ↗InjuryMay 24, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25267183 ↗InjuryMay 11, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25135551 ↗InjuryMay 5, 2026Failure to Osseointegrate
InjuryApr 29, 2026Failure to Osseointegrate
InjuryApr 20, 2026Failure to Osseointegrate
InjuryApr 11, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24847186 ↗InjuryApr 8, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24820463 ↗InjuryApr 7, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24803823 ↗InjuryMar 17, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryFeb 26, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24461529 ↗InjuryFeb 26, 2026Failure to Osseointegrate
InjuryFeb 23, 2026Failure to Osseointegrate
InjuryFeb 19, 2026Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24388937 ↗
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.