BioHorizons 40105D3Recalls & reported problems
Biohorizons Implant Systems, Inc · External Implant RBT, D3 Threadform 4.0 x 10.5mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons 40105D3 threaded dental implant is a root-form screw placed in the jaw. The 28 reports mostly describe the implant failing to fuse with the surrounding bone, with a couple mentioning the implant fracturing. All 28 reports involve injuries and no deaths; reports doubled from 9 in the earlier 12 months to 18 in the most recent 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00847236000080), received between Jun 20, 2024 and Aug 28, 2026 — classified as 28 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (26 reports).
1 other recall cover devices cleared under the same FDA submission (K030463); 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 Osseointegrate26
- Fracture2
- Use of Device Problem1
Patient problems
- Insufficient Information28
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2026Failure to Osseointegrate
InjuryAug 28, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50496400 ↗InjuryAug 28, 2026Failure to Osseointegrate
Patient problems: Insufficient Information
MAUDE report 50496393 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryJul 1, 2026Failure to Osseointegrate
InjuryJul 1, 2026Failure to Osseointegrate
InjuryJul 1, 2026Failure to Osseointegrate
InjuryJun 30, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryMay 7, 2026Failure to Osseointegrate
InjuryMay 5, 2026Failure to Osseointegrate
InjuryApr 24, 2026Failure to Osseointegrate
InjuryDec 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 28, 2025Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
InjuryDec 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 4, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22143185 ↗InjuryJun 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 9, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 24, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K030463. One submission often covers many models, so check the product and lot details in each record.
- Z-1058-2014 · Dec 10, 2013 · TerminatedExternal Implant RBT, D3 Threadform 4.0 X 10.5mm, REF 40105D3, STERILE R, Rx Only, BioHorizons(R), 2300 Riverchase Center, Birmingham, AL 35244 Usage: dental
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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