BioHorizons TLR5807Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Internal Implant RBT, Laser-Lok 5.8 x 7.5mm, 5.7 Platform · Class 2 · Implant
Quick summary
This BioHorizons Tapered Internal dental implant is a root-form implant placed in the jawbone. The FDA records hold 96 reports, with no deaths and 96 injuries; most describe the implant failing to bond with the bone. Reports fell to 13 in the last 12 months from 49 in the prior 12 months. 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
- 97
- Deaths reported
- 0
- Injuries reported
- 97
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 00847236009946), received between Feb 24, 2024 and Sep 30, 2026 — classified as 97 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (88 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 Osseointegrate88
- Use of Device Problem9
- Loss of Osseointegration2
Patient problems
- Insufficient Information97
Recent adverse event reports
The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
InjuryJul 2, 2026Failure to Osseointegrate
InjuryApr 8, 2026Failure to Osseointegrate
InjuryJan 28, 2026Use of Device Problem
InjuryJan 9, 2026Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 24, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23640219 ↗InjuryNov 18, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23366453 ↗InjuryOct 16, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 18, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23084665 ↗InjurySep 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 30, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22366664 ↗
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.