BioHorizons CTA4615Recalls & reported problems
Biohorizons Implant Systems, Inc · Tapered Pro Conical Implant, 4.6 x 15mm, Laser-Lok and RBT · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This BioHorizons tapered conical dental implant is a root-form screw placed in the jawbone. The 65 reports mostly describe implants that fail to fuse with the bone, so they have to be taken back out, sometimes within a day or two of surgery; one report mentions a fracture and a connection problem. No deaths were reported, and all 65 involved injuries. There are no recalls naming this device, and reports rose from 15 in the prior 12 months to 44 in the last 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
- 63
- Deaths reported
- 0
- Injuries reported
- 63
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00847236024208), received between Sep 6, 2024 and Sep 10, 2026 — classified as 63 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (43 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem43
- Failure to Osseointegrate28
- Connection Problem1
- Fracture1
Patient problems
- Insufficient Information63
- Encephalocele1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50710512 ↗InjurySep 10, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50709493 ↗InjurySep 8, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50679419 ↗InjuryAug 31, 2026Use of Device Problem; Failure to Osseointegrate
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50522925 ↗InjuryAug 6, 2026Use of Device Problem
Implant removed due to surgical consideration within 36 hours.
Patient problems: Insufficient Information
MAUDE report 50154401 ↗InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryAug 5, 2026Failure to Osseointegrate
InjuryJun 17, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 3, 2026Failure to Osseointegrate
InjuryJun 3, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25377178 ↗InjuryMay 26, 2026Failure to Osseointegrate
InjuryMay 11, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 25135557 ↗InjuryMay 6, 2026Use of Device Problem; Failure to Osseointegrate
InjuryApr 22, 2026Use of Device Problem; Failure to Osseointegrate
InjuryApr 22, 2026Use of Device Problem; Failure to Osseointegrate
InjuryApr 15, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS
Patient problems: Insufficient Information
MAUDE report 24889655 ↗InjuryApr 11, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24847529 ↗InjuryApr 11, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24847162 ↗InjuryApr 6, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24790939 ↗InjuryApr 1, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24753859 ↗InjuryApr 1, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24753542 ↗InjuryMar 22, 2026Use of Device Problem
IMPLANT REMOVED DUE TO SURGICAL CONSIDERATION WITHIN 36 HOURS.
Patient problems: Insufficient Information
MAUDE report 24658585 ↗InjuryMar 12, 2026Failure to Osseointegrate
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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