BioHorizons IL-5007Recalls & reported problems
Biohorizons Implant Systems, Inc · Fusion 5.0 x 7.5mm Implant, Yellow Platform, Ossean, Blossom · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00847236016166), received between Feb 24, 2024 and Jul 12, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate18
- Use of Device Problem3
- Loss of Osseointegration1
Patient problems
- Insufficient Information19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2026Failure to Osseointegrate
InjuryJun 26, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryFeb 26, 2026Failure to Osseointegrate
InjuryFeb 23, 2026Use of Device Problem; Failure to Osseointegrate
InjuryDec 21, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryApr 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 27, 2024Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20799536 ↗InjurySep 9, 2024Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 20176092 ↗InjuryMay 23, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryMar 20, 2024Failure to Osseointegrate; Loss of Osseointegration; Failure to Osseointegrate; Loss of Osseointegration
InjuryFeb 24, 2024Failure 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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