BioHorizons IL-4209Recalls & reported problems
Biohorizons Implant Systems, Inc · Fusion 4.2 x 9mm Implant, Yellow Platform, Ossean, Blossom · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons Fusion dental implant is a screw-shaped implant placed in the jawbone to support a replacement tooth. Most of the 32 reports describe the implant failing to fuse with the surrounding bone, so it never becomes stable in place. There are 32 injuries and no deaths, and no recalls name this device. Reports have slowed recently, with 6 in the past 12 months compared with 21 in the prior 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00847236016128), received between Jun 1, 2024 and Jun 29, 2026 — classified as 31 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (29 reports).
1 other recall cover devices cleared under the same FDA submission (K121787, 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 Osseointegrate29
- Use of Device Problem2
Patient problems
- Insufficient Information31
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryFeb 23, 2026Failure to Osseointegrate
InjuryFeb 23, 2026Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 19, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 8, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 10, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21814659 ↗InjuryApr 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 25, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21389372 ↗InjuryFeb 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 22, 2025Failure to Osseointegrate; Failure to Osseointegrate
Recalls under the same FDA submission
These recalls involve devices cleared under K121787, 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 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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