BioHorizons CTR4607Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Short Conical Implant 4.6 x 7.5mm, RBT · 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 00847236024390), received between Apr 1, 2025 and Aug 10, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (16 reports).
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 Osseointegrate16
- Use of Device Problem4
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.
InjuryAug 10, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJul 10, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 1, 2026Failure to Osseointegrate
InjuryMay 24, 2026Failure to Osseointegrate
InjuryApr 10, 2026Failure to Osseointegrate
InjuryMar 18, 2026Failure to Osseointegrate
InjuryMar 10, 2026Failure to Osseointegrate
InjuryFeb 27, 2026Failure to Osseointegrate
InjuryFeb 13, 2026Failure to Osseointegrate
InjuryDec 31, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 23936327 ↗InjuryDec 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryMay 27, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 22086809 ↗InjuryMay 8, 2025Use of Device Problem; Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 21984172 ↗InjuryApr 1, 2025Use of Device Problem; Failure to Osseointegrate; Use of Device Problem; Failure to Osseointegrate
Other Implant, Endosseous, Root-Form devices
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- 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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